---
title: Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer
nct_id: NCT01781338
overall_status: COMPLETED
phase: PHASE2, PHASE3
sponsor: West German Study Group
study_type: INTERVENTIONAL
primary_condition: Breast Cancer
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01781338.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01781338"
ct_last_update_post_date: 2025-02-27
last_seen_at: "2026-05-12T07:31:10.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer

**NCT ID:** [NCT01781338](https://clinicaltrials.gov/study/NCT01781338)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2, PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 4936
- **Lead Sponsor:** West German Study Group
- **Conditions:** Breast Cancer
- **Start Date:** 2012-05
- **Completion Date:** 2025-01-15
- **CT.gov Last Update:** 2025-02-27

## Brief Summary

Trial for the optimization of risk assessment and therapy success prediction in patients with early breast cancer by the use of biomarkers in advance to therapy decision-making to personalize therapies.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for ADAPT Elderly)
* Histologically confirmed unilateral primary invasive carcinoma of the breast
* Clinical T1 - T4 (except inflammatory breast cancer)
* All clinical N (cN)
* No clinical evidence for distant metastasis (M0)
* Known HR status and HER2 status (local pathology)
* Tumor block available for central pathology review
* Performance Status ECOG \<= 1 or KI \>= 80%
* Negative pregnancy test (urine or serum) within 7 days prior to start of induction treatment in premenopausal patients
* Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
* The patient must be accessible for treatment and follow-up

Exclusion Criteria:

* Known hypersensitivity reaction to the compounds or incorporated substances
* Prior malignancy with a disease-free survival of \< 10 years, except curatively treated basalioma of the skin or pTis of the cervix uteri
* Non-operable breast cancer including inflammatory breast cancer
* Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor
* Concurrent treatment with other experimental drugs. Participation in another interventional clinical trial with or without any investigational not marketed drug within 30 days prior to study entry
* Male breast cancer
* Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
* Breast feeding woman
* Sequential breast cancer
* Reasons indicating risk of poor compliance
* Patients not able to consent
```

## Arms

- **Induction Therapy** (EXPERIMENTAL) — The kind of induction therapy is dependent on the respective sub-protocol.

## Interventions

- **Induction therapy** (OTHER) — The intervention is dependent on the respective sub-protocol and can include either endocrine therapy, neoadjuvant chemotherapy or targeted therapy.

## Primary Outcomes

- **Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11** _(time frame: 8 years)_ — In order to identify patients that are at comparable low risk as hormone receptor positive, HER2 negative patients with low Recurrence Score, any sub-population across the sub-trials will be compared to this risk group.

## Secondary Outcomes

- **Overall survival** _(time frame: 8 years)_

## Locations (2)

- Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern, Munich, Bavaria, Germany
- Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, North Rhine-Westphalia, Germany

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.breast center of the university of munich (lmu) universitätsfrauenklinik großhadern|munich|bavaria|germany` — added _(2026-05-12)_
- `locations.ev. krankenhaus bethesda brustzentrum niederrhein|mönchengladbach|north rhine-westphalia|germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01781338.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01781338*  
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