---
title: A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer
nct_id: NCT01101438
overall_status: COMPLETED
phase: PHASE3
sponsor: Canadian Cancer Trials Group
study_type: INTERVENTIONAL
primary_condition: Breast Cancer
countries: United States, Canada, Switzerland, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01101438.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01101438"
ct_last_update_post_date: 2023-09-13
last_seen_at: "2026-05-12T06:43:57.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer

**Official Title:** A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer

**NCT ID:** [NCT01101438](https://clinicaltrials.gov/study/NCT01101438)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 3649
- **Lead Sponsor:** Canadian Cancer Trials Group
- **Collaborators:** National Cancer Institute (NCI), ETOP IBCSG Partners Foundation, Institute of Cancer Research, United Kingdom
- **Conditions:** Breast Cancer
- **Start Date:** 2010-08-13
- **Completion Date:** 2023-08-18
- **CT.gov Last Update:** 2023-09-13

## Brief Summary

This study is looking at whether Metformin, an agent that is commonly used to treat diabetes, can decrease or affect the ability of breast cancer cells to grow and whether Metformin will work with other therapies to keep cancer from recurring. Health Canada has not approved the sale or use of Metformin to treat breast cancer, although they have approved its use in this clinical trial. Although Metformin is approved by the FDA for the treatment of diabetes, its use in breast cancer is considered investigational.

## Detailed Description

This is a multicenter study. Patients are stratified according to hormone-receptor status (estrogen receptor- and/or progesterone receptor- positive vs both receptors negative), body mass index (≤ 30 vs \> 30 kg/m²), HER2 status (positive vs negative), and prior chemotherapy (any vs none). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral metformin hydrochloride twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive oral placebo twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.

Blood and tumor samples are collected periodically for correlative studies.

Patients may complete quality-of-life, physical activity, and diet questionnaires at baseline and at 6, 12, 24, 36, 48, and 60 months. (Sub-set of patients).

After completion of study treatment, patients are followed annually.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 74 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Eligibility Criteria:

* Subjects must have histologically confirmed invasive breast cancer and be enrolled in the trial within 12 months after the first histologic diagnosis of invasive breast cancer. A core biopsy interpreted as invasive cancer meets this criterion; otherwise, the date of first histologic diagnosis will be the date of first surgical procedure that identifies invasive cancer (biopsy, lumpectomy or mastectomy). Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery. Bilateral breast carcinoma is allowed provided diagnoses are synchronous - that is, within 3 months of one another - and at least one of the two breast carcinomas meet the eligibility criteria and neither violates the eligibility criteria.
* All subjects (both adjuvant and neo-adjuvant) must have sentinel lymph node biopsy and/or axillary lymph node dissection.

Sentinel lymph node biopsy alone is allowed in the following instances:

1. sentinel lymph node biopsy is negative: pN0
2. sentinel lymph node biopsy is positive for isolated tumour cells only: pN0 (i+)
3. \* clinically node negative, T1-2 tumours with sentinel lymph node biopsy positive in ≤ 2 lymph nodes without extra-capsular extension or matted nodes and undergoing breast conserving surgery and tangential whole breast irradiation (\* excludes subjects treated with neo-adjuvant systemic therapy)

Definitive surgery and/or chemotherapy have been completed at least 4 weeks prior to randomization. Surgical margins must be clear of invasive carcinoma. If there is microscopic residual ductal in situ disease present at lumpectomy or total mastectomy margins, further excision is highly recommended. If further excision is not undertaken, the subject may still be entered on study, provided that in addition to breast or chest wall irradiation, a boost to the tumour bed is delivered. In situ lobular disease at the margin is acceptable.

Adjuvant subjects with the following pT pN combinations are eligible:

* pT1c, pN0 AND negative estrogen and progesterone receptors AND HER2 negative OR
* pT2N0 and at least one of the following tumour characteristics: histologic grade 3, lymphovascular invasion, negative estrogen and progesterone receptors, HER2 positive, Oncotype Dx recurrence score ≥ 25 (or if Oncotype Dx recurrence score is not available, Ki67 \> 14%) OR
* Subjects with pT3, pN0 OR
* Subjects with pT1-3, pN1-3

The eligibility of neo-adjuvant subjects is assessed on the basis of cTNM. The same eligible TNM combinations apply.

* HER2 status must be known. (Positive = 3+ over-expression by IHC in \> 30% of invasive tumour cells OR HER2 gene amplification by FISH/CISH \> 6 HER2 gene copies per nucleus, OR a FISH/CISH ratio: HER2 gene copies to chromosome 17 signals of ≥ 2.2. All other results will be considered negative).
* Patients must have had a bilateral mammogram within 12 months prior to randomization, unless the initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required. (Subjects with bilateral total mastectomies and no mammogram within 12 months prior to randomization must, instead, have a physical examination of the chest wall to ensure there is no residual or recurrent disease at the time of randomization. The date of this examination is used in place of the mammogram date on the eligibility checklist.)
* Investigations, including chest X-ray or CT chest, bone scan (with radiographs of suspicious areas) and abdominal ultrasound or liver scan or CT abdomen have been performed between the first histologic diagnosis and the time of randomization.

  * Chest X-Ray, 2 view (or Chest CT) is mandatory
  * Bone scans (with x-rays of abnormal areas) are required only if there are signs or symptoms of metastatic disease
  * Abdominal imaging is required only if there are signs or symptoms of metastatic disease
* Hematology investigations (WBC, Granulocytes, Platelets, Hemoglobin) have been completed within 28 days prior to randomization and results are available.
* Biochemistry investigations have been completed within 28 days prior to randomization and values are within the parameters required by the protocol.

AST \< 1.8 X ULN; ALT \< 1.8 X ULN; Alkaline Phosphatase \< 2 X ULN; Serum Creatinine \< 115 μmol/L (1.3mg/dL) Serum Bilirubin \< institution ULN (except for subjects with Gilbert's Disease who are eligible despite elevated serum bilirubin level)

* ECOG Performance Status of 0,1 or 2 (at baseline evaluation visit within 28 days prior to randomization).
* Age ≥ 18 and \< 75 and life expectancy of at least 5 years (18 years of age was used as a cut-off due to the lack of data indicating that breast cancer is a health issue in the \< 18 years age group and metformin safety in pediatric patients has not been confirmed. Age \> 80 carries increased risk of lactic acidosis and study intervention is for 5 years).
* Subjects must be accessible for treatment and follow-up. Investigators must assure themselves the subjects randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
* In accordance with NCIC CTG policy, protocol treatment is to begin within 10 working days of patient randomization.
* Subject consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the NCIC CTG Study Coordinator that such clearance has been obtained, before the trial can commence in that centre. Because of differing requirements, a standard consent form for the trial will not be provided but a sample form is given. A copy of the initial full board REB approval and approved consent form must be sent to the central office. The patient must sign the consent form prior to randomization or registration. Please note that the consent form for this study must contain a statement which gives permission for the NCIC CTG and monitoring agencies to review patient records (see Section 16 for further details).

For the first 888 eligible English or French-speaking subjects only (sub-set enrollment completed 2011NOV04):

* Subject is able (i.e. sufficiently fluent) and willing to complete the Quality of Life (EORTC QLQ C-30 and Trial Specific Checklist) in English or French. The baseline assessment must already have been completed at the time of enrollment. Inability (illiteracy in English or French, loss of sight or other equivalent reason) to complete questionnaires will not make the patient ineligible for the study; however, ability but unwillingness to complete the questionnaires will make the patient ineligible. (Once the target number of 888 subjects is achieved, this criterion will no longer need to be fulfilled.) \[See Appendix VI\]. Sub-set enrollment completed 2011NOV04.
* English-speaking subjects who have completed the Quality of Life Questionnaire who are able (i.e. sufficiently fluent) and willing to complete Nurses Health Study II Physical Activity Questionnaire and Block Alive Screener in English. The baseline assessment must already have been completed at the time of enrollment. Inability (illiteracy in English, loss of sight or other equivalent reason) to complete questionnaires will not make the patient ineligible for the study; however, ability but unwillingness to complete the questionnaires will make the patient ineligible. (This component of the study will close at the same time as the Quality Of Life sub-study.) Closed to new patient enrollment as of 2011NOV04.

Ineligibility Criteria:

* Subjects with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
* Subjects with locally recurrent or metastatic breast carcinoma. (Subjects with prior invasive breast cancer at any time are not eligible. Subjects with prior DCIS only in either breast are eligible provided the DCIS has been curatively treated including surgery, radiotherapy and/or Tamoxifen).
* Subjects whose axillary node status is unknown.
* Known diabetes (type 1 or 2) or baseline fasting glucose \> 7.0 mmol/L (126 mg/dL). (Sampled and assayed according to local institution's procedures.)
* Known hypersensitivity or intolerance to metformin.
* Any condition associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heart failure defined as New York Heart Association {NYHA} Class III or IV functional status \[see Appendix IX\], history of acidosis of any type; habitual \* Currently taking metformin, sulfonylureas, thiazolidinediones or insulin for any reason.
* Current or planned pregnancy or lactation in women of child-bearing potential. Men should not father a child. (An effective method of birth control should be used while on study treatment which could include abstinence, IUD, condoms or other barrier methods of birth control because the safety of metformin in pregnancy or in male fertility has not been established).
* Concurrent or planned participation in randomized trials of weight loss or exercise interventions or trials targeting insulin, IGF-1 or their receptors, or involving P13K inhibitors (at the time of randomization)\*.
* These interventions would interfere with the primary endpoint. (Also, in general, double randomizations in breast cancer trials for MA.32 patients are permitted only if the patient meets all the eligibility criteria for MA.32 and the sponsor of the previous trial has no objection to the patient also being enrolled in MA.32).
```

## Arms

- **Arm I** (EXPERIMENTAL) — Patients receive oral metformin hydrochloride twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
- **Arm II** (PLACEBO_COMPARATOR) — Patients receive oral placebo twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.

## Interventions

- **metformin hydrochloride** (DRUG) — Given orally
- **placebo** (OTHER) — Given orally

## Primary Outcomes

- **Invasive Disease-free Survival in Hormone Receptor (ER and PgR) Positive Sub-groups** _(time frame: 5 years)_ — Invasive disease-free survival (IDFS) is defined as percentage of patients without documented development of ipsilateral and contralateral invasive breast tumour, local/regional invasive recurrence, distant recurrence, death from any causes. If a subject has not had invasive disease or died at the time of data cut-off for this final analysis, IDFS was censored on the date of last follow-up.
- **Invasive Disease-free Survival** _(time frame: 5 years)_ — Invasive disease-free survival (IDFS) is defined as the percent of patients without documented development of ipsilateral and contralateral invasive breast tumour, local/regional invasive recurrence, distant recurrence, death from any causes. If a subject has not had invasive disease or died at the time of data cut-off for this final analysis, IDFS was censored on the date of last follow-up.

## Secondary Outcomes

- **Overall Survival** _(time frame: 10 years)_
- **Distant Relapse-free Survival** _(time frame: 5 years)_
- **Breast Cancer-specific Mortality** _(time frame: 10 years)_

## Locations (344)

- Providence Alaska Medical Center, Anchorage, Alaska, United States
- Fairbanks Memorial Hospital, Fairbanks, Alaska, United States
- Pinnacle Oncology Associates, Scottsdale, Arizona, United States
- Mayo Clinic in Arizona, Scottsdale, Arizona, United States
- Arizona Cancer Center at University Medical Center North, Tucson, Arizona, United States
- University of Arizona Health Sciences Center, Tucson, Arizona, United States
- Kaiser Permanente-Deer Valley Medical Center, Antioch, California, United States
- Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, United States
- Enloe Medical Center, Chico, California, United States
- Glendale Memorial Hospital and Health Center, Glendale, California, United States
- Kaiser Permanente, Hayward, Hayward, California, United States
- Moores University of California San Diego Cancer Center, La Jolla, California, United States
- Long Beach Memorial Medical Center-Todd Cancer Institute, Long Beach, California, United States
- University of Southern California, Los Angeles, California, United States
- University of California at Los Angeles (UCLA ), Los Angeles, California, United States
- Fremont - Rideout Cancer Center, Marysville, California, United States
- Bay Area Tumor Institution CCOP, Oakland, California, United States
- Kaiser Permanente-Oakland, Oakland, California, United States
- University of California Medical Center At Irvine-Orange Campus, Orange, California, United States
- Pomona Valley Hospital Medical Center, Pomona, California, United States
- Kaiser Permanente-Redwood City, Redwood City, California, United States
- Kaiser Permanente-Richmond, Richmond, California, United States
- Kaiser Permanente-Roseville, Roseville, California, United States
- University of California Davis-Cancer Center, Sacramento, California, United States
- Kaiser Permanente-South Sacramento, Sacramento, California, United States
- Kaiser Permanente - Sacramento, Sacramento, California, United States
- Kaiser Permanente-Mission, San Diego, California, United States
- Kaiser Permanente, San Diego, California, United States
- Kaiser Permanente-San Francisco, San Francisco, California, United States
- University of California San Francisco Medical Center-Mount Zion, San Francisco, California, United States
- Kaiser Permanente-Santa Teresa-San Jose, San Jose, California, United States
- Kaiser Permanente-San Rafael, San Rafael, California, United States
- Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, United States
- Kaiser Permanente-Santa Rosa, Santa Rosa, California, United States
- Kaiser Permanente-South San Francisco, South San Francisco, California, United States
- Stanford University, Stanford, California, United States
- Kaiser Permanente-Stockton, Stockton, California, United States
- Tahoe Forest Cancer Center, Truckee, California, United States
- Kaiser Permanente Medical Center-Vacaville, Vacaville, California, United States
- Kaiser Permanente-Vallejo, Vallejo, California, United States
- Kaiser Permanente-Walnut Creek, Walnut Creek, California, United States
- John Muir Medical Center, Walnut Creek, California, United States
- University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, Colorado, United States
- Memorial Hospital Colorado Springs, Colorado Springs, Colorado, United States
- Kaiser Permanente-Franklin, Denver, Colorado, United States
- Poudre Valley Hospital, Fort Collins, Colorado, United States
- Front Range Cancer Specialists, Fort Collins, Colorado, United States
- University of Connecticut, Farmington, Connecticut, United States
- Greenwich Hospital, Greenwich, Connecticut, United States
- Hartford Hospital, Hartford, Connecticut, United States
- Yale University, New Haven, Connecticut, United States
- Stamford Hospital, Stamford, Connecticut, United States
- Connecticut Oncology and Hematology LLP, Torrington, Connecticut, United States
- Georgetown University Hospital, Washington D.C., District of Columbia, United States
- Washington Hospital Center, Washington D.C., District of Columbia, United States
- Sibley Memorial Hospital, Washington D.C., District of Columbia, United States
- Boca Raton Regional Hospital, Boca Raton, Florida, United States
- Mayo Clinic in Florida, Jacksonville, Florida, United States
- The Watson Clinic, Lakeland, Florida, United States
- Mount Sinai Medical Center CCOP, Miami Beach, Florida, United States
- Florida Hospital, Orlando, Florida, United States
- Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
- Phoebe Putney Memorial Hospital, Albany, Georgia, United States
- Northeast Georgia Medical Center, Gainesville, Georgia, United States
- South Georgia Medical Center, Valdosta, Georgia, United States
- University of Hawaii, Honolulu, Hawaii, United States
- Kaiser Permanente Moanalua Medical Center, Honolulu, Hawaii, United States
- Rush - Copley Medical Center, Aurora, Illinois, United States
- Mount Sinai Hospital Medical Center, Chicago, Illinois, United States
- John H Stroger Jr Hospital of Cook County, Chicago, Illinois, United States
- Swedish Covenant Hospital, Chicago, Illinois, United States
- Resurrection Healthcare, Chicago, Illinois, United States
- University of Chicago, Chicago, Illinois, United States
- Decatur Memorial Hospital, Decatur, Illinois, United States
- Elmhurst Memorial Hospital, Elmhurst, Illinois, United States
- Evanston CCOP-NorthShore University HealthSystem, Evanston, Illinois, United States
- Saint Francis Hospital, Evanston, Illinois, United States
- Ingalls Memorial Hospital, Harvey, Illinois, United States
- Loyola University Medical Center, Maywood, Illinois, United States
- Trinity Medical Center, Moline, Illinois, United States
- Illinois CancerCare-Peoria, Peoria, Illinois, United States
- Illinois Oncology Research Association CCOP, Peoria, Illinois, United States
- Memorial Medical Center, Springfield, Illinois, United States
- Carle Foundation - Carle Cancer Center, Urbana, Illinois, United States
- Elkhart Clinic, Elkhart, Indiana, United States
- Michiana Hematology Oncology PC-Elkhart, Elkhart, Indiana, United States
- Indiana University Hospital/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
- Howard Regional Healthcare System, Kokomo, Indiana, United States
- Saint Anthony Memorial Health Center, Michigan City, Indiana, United States
- Michiana Hematology Oncology PC-Mishawaka, Mishawaka, Indiana, United States
- Michiana Hematology Oncology PC-Plymouth, Plymouth, Indiana, United States
- Michiana Hematology Oncology PC-South Bend, South Bend, Indiana, United States
- Michiana Hematology Oncology-PC Westville, Westville, Indiana, United States
- McFarland Clinic, Ames, Iowa, United States
- Oncology Associates at Mercy Medical Center, Cedar Rapids, Iowa, United States
- Heartland Oncology and Hematology LLP, Council Bluffs, Iowa, United States
- Ottumwa Regional Health Center, Ottumwa, Iowa, United States
- Siouxland Hematology Oncology Associates, Sioux City, Iowa, United States
- Kansas City CCOP, Prairie Village, Kansas, United States
- Wichita CCOP, Wichita, Kansas, United States
- Central Baptist Hospital, Lexington, Kentucky, United States
- Owensboro Mercy Medical Center, Owensboro, Kentucky, United States
- Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States
- Eastern Maine Medical Center, Bangor, Maine, United States
- York Hospital, York Village, Maine, United States
- University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States
- Mercy Medical Center, Baltimore, Maryland, United States
- Johns Hopkins University, Baltimore, Maryland, United States
- Suburban Hospital, Bethesda, Maryland, United States
- Frederick Memorial Hospital, Frederick, Maryland, United States
- Dana-Farber Cancer Institute, Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
- Lahey Clinic Medical Center, Burlington, Massachusetts, United States
- Addison Gilbert Hospital, Gloucester, Massachusetts, United States
- Lowell General Hospital, Lowell, Massachusetts, United States
- Saint Vincent Hospital - Fallon Clinic, Worcester, Massachusetts, United States
- University of Michigan Health System-Cancer Center, Ann Arbor, Michigan, United States
- Battle Creek Health System, Battle Creek, Michigan, United States
- Wayne State University, Detroit, Michigan, United States
- Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, United States
- Saint Mary's Health Care, Grand Rapids, Michigan, United States
- Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, United States
- West Michigan Cancer Center, Kalamazoo, Michigan, United States
- Mercy Health Partners-Mercy Campus, Muskegon, Michigan, United States
- Michiana Hematology Oncology PC-Niles, Niles, Michigan, United States
- William Beaumont Hospital, Royal Oak, Michigan, United States
- Marie Yeager Cancer Center, Saint Joseph, Michigan, United States
- Munson Medical Center, Traverse City, Michigan, United States
- Metro Health Hospital, Wyoming, Michigan, United States
- Mercy Hospital, Coon Rapids, Minnesota, United States
- Duluth Clinic CCOP, Duluth, Minnesota, United States
- Fairview-Southdale Hospital, Edina, Minnesota, United States
- Unity Hospital, Fridley, Minnesota, United States
- Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States
- Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States
- Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
- North Memorial Medical Health Center, Robbinsdale, Minnesota, United States
- Mayo Clinic, Rochester, Minnesota, United States
- CentraCare Clinic, Saint Cloud, Minnesota, United States
- Metro-Minnesota CCOP, Saint Louis Park, Minnesota, United States
- Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
- Regions Hospital, Saint Paul, Minnesota, United States
- United Hospital, Saint Paul, Minnesota, United States
- Rice Memorial Hospital, Willmar, Minnesota, United States
- Minnesota Oncology and Hematology PA-Woodbury, Woodbury, Minnesota, United States
- University of Mississippi Medical Center, Jackson, Mississippi, United States
- Singing River Hospital, Pascagoula, Mississippi, United States
- Saint Luke's Hospital, Chesterfield, Missouri, United States
- Saint John's Hospital, Springfield, Missouri, United States
- Cox Medical Center, Springfield, Missouri, United States
- Washington University School of Medicine, St Louis, Missouri, United States
- Missouri Baptist Medical Center, St Louis, Missouri, United States
- Saint John's Mercy Medical Center, St Louis, Missouri, United States
- Saint Louis-Cape Girardeau CCOP, St Louis, Missouri, United States
- Good Samaritan Hospital, Kearney, Nebraska, United States
- Lincoln Medical Education Foundation Cancer Resource Center, Lincoln, Nebraska, United States
- Missouri Valley Cancer Consortium CCOP, Omaha, Nebraska, United States
- Methodist Estabrook Cancer Center, Omaha, Nebraska, United States
- New Hampshire Oncology-Hematology PA, Concord, New Hampshire, United States
- New Hampshire Oncology Hematology Associates, Hooksett, New Hampshire, United States
- LRGHealthcare-Lakes Region General Hospital, Laconia, New Hampshire, United States
- Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
- The Dana-Farber Cancer Institute at Londonderry, Londonderry, New Hampshire, United States
- Saint Barnabas Medical Center, Livingston, New Jersey, United States
- Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County, Mount Holly, New Jersey, United States
- Valley Hospital, Ridgewood, New Jersey, United States
- University of New Mexico, Albuquerque, New Mexico, United States
- Presbyterian Kaseman Hospital, Albuquerque, New Mexico, United States
- State University of New York Downstate Medical Center, Brooklyn, New York, United States
- Maimonides Medical Center, Brooklyn, New York, United States
- Coney Island Hospital, Brooklyn, New York, United States
- Roswell Park Cancer Institute, Buffalo, New York, United States
- Hematology Oncology Associates of Central New York PC, East Syracuse, New York, United States
- Monter Cancer Center, Lake Success, New York, United States
- North Shore University Hospital CCOP, Manhasset, New York, United States
- North Shore University Hospital, Manhasset, New York, United States
- Mount Kisco Medical Group at Northern Westchester Hospital, Mount Kisco, New York, United States
- Mount Kisco Medical Group, Mount Kisco, New York, United States
- Long Island Jewish Medical Center, New Hyde Park, New York, United States
- Beth Israel Medical Center, New York, New York, United States
- New York University Langone Medical Center, New York, New York, United States
- Saint Luke's Roosevelt Hospital Center - Saint Luke's Division, New York, New York, United States
- Mount Sinai Medical Center, New York, New York, United States
- Columbia University Medical Center, New York, New York, United States
- Rochester General Hospital, Rochester, New York, United States
- Stony Brook University Medical Center, Stony Brook, New York, United States
- State University of New York Upstate Medical University, Syracuse, New York, United States
- Albert Einstein College of Medicine, The Bronx, New York, United States
- The North Division of Montefiore Medical Center, The Bronx, New York, United States
- Montefiore Medical Center, The Bronx, New York, United States
- Mission Hospitals Inc, Asheville, North Carolina, United States
- Presbyterian Hospital, Charlotte, North Carolina, United States
- Wayne Memorial Hospital, Goldsboro, North Carolina, United States
- Margaret R Pardee Memorial Hospital, Hendersonville, North Carolina, United States
- High Point Regional Hospital, High Point, North Carolina, United States
- Kinston Medical Specialists PA, Kinston, North Carolina, United States
- FirstHealth of the Carolinas-Moore Regional Hosiptal, Pinehurst, North Carolina, United States
- Rex Cancer Center, Raleigh, North Carolina, United States
- Forsyth Memorial Hospital, Winston-Salem, North Carolina, United States
- Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
- _and 144 more_

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- `locations.avera cancer institute|sioux falls|south dakota|united states` — added _(2026-05-12)_
- `locations.university of tennessee - knoxville|knoxville|tennessee|united states` — added _(2026-05-12)_
- `locations.rockwood clinic|spokane|washington|united states` — added _(2026-05-12)_
- `locations.vanderbilt breast center at one hundred oaks|nashville|tennessee|united states` — added _(2026-05-12)_
- `locations.vanderbilt university|nashville|tennessee|united states` — added _(2026-05-12)_
- `locations.university medical center brackenridge|austin|texas|united states` — added _(2026-05-12)_
- `locations.doctor's hospital of laredo|laredo|texas|united states` — added _(2026-05-12)_
- `locations.university of texas health science center|san antonio|texas|united states` — added _(2026-05-12)_
- `locations.huntsman cancer institute/university of utah|salt lake city|utah|united states` — added _(2026-05-12)_
- `locations.mountainview medical|berlin corners|vermont|united states` — added _(2026-05-12)_
- `locations.university of vermont|burlington|vermont|united states` — added _(2026-05-12)_
- `locations.martha jefferson hospital|charlottesville|virginia|united states` — added _(2026-05-12)_

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*Canonical: https://parkinsonspathways.com/agent/trials/NCT01101438.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01101438*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*