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Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer

Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer

Inclusion Criteria:

- Female patients, age at diagnosis 18 - 75 years

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11

Outcome Description:

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.

Outcome Time Frame:

8 years

Safety Issue:


Principal Investigator

Nadia Harbeck, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern, Munich, Germany


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

May 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms