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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

Additional Inclusion criteria for patients receiving chemotherapy:

- Laboratory requirements for patients receiving neoadjuvant chemotherapy (within 14
days prior to induction treatment):

- Leucocytes >= 3.5 x 10^9/L

- Platelets >= 100 x 10^9/L

- Hemoglobin >= 10 g/dL

- Total bilirubin <= 1 x ULN

- ASAT (SGOT) and ALAT (SGPT) <= 2.5 x UNL

- Creatinine <= 175 µmol/L (2 mg/dl)

- LVEF within normal limits of each institution measured by echocardiography and normal
ECG (within 42 days prior to induction treatment)

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

Additional Exclusion Criteria for patients receiving chemotherapy:

- Known polyneuropathy ≥ grade 2

- Severe and relevant co-morbidity that would interact with the application of
cytotoxic agents or the participation in the study including acute cystitis and
ischuria and chronic kidney disease

- Uncompensated cardiac function

- Inadequate organ function including:

- Leucocytes < 3.5 x 10^9/l

- Platelets < 100 x 10^9/l

- Bilirubin above normal limits

- Alkaline phosphatase >= 5 x UNL

- ASAT and/or ALAT associated with AP > 2.5 x UNL

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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 Time Frame:

3 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