ADAPT - Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer (ADAPT)
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ClinicalTrials.gov Identifier: NCT01779206 |
Recruitment Status :
Active, not recruiting
First Posted : January 30, 2013
Last Update Posted : February 7, 2020
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Drug: Epirubicin Drug: Cyclophosphamide Drug: Docetaxel Drug: Paclitaxel | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 4936 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer |
Actual Study Start Date : | May 2012 |
Actual Primary Completion Date : | September 2019 |
Estimated Study Completion Date : | September 2024 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Anthracycline - Taxane
Study sites can choose between either Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q3w OR Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q2w for anthracycline treatment and between either 4 x Docetaxel (100mg/m²) q3w OR 12 x Paclitaxel (80mg/m²) q1w for taxane treatment.
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Drug: Epirubicin Drug: Cyclophosphamide Drug: Docetaxel Drug: Paclitaxel |
Experimental: Taxane - Anthracycline
Study sites can choose between either Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q3w OR Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q2w for anthracycline treatment and between either 4 x Docetaxel (100mg/m²) q3w OR 12 x Paclitaxel (80mg/m²) q1w for taxane treatment.
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Drug: Epirubicin Drug: Cyclophosphamide Drug: Docetaxel Drug: Paclitaxel |
- Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11 [ Time Frame: 3 Years ]
- Overall survival [ Time Frame: 3 Years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts 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
Additional Inclusion criteria for patients receiving chemotherapy:
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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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01779206
Germany | |
Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern | |
Munich, Bavaria, Germany, 81377 | |
Ev. Krankenhaus Bethesda Brustzentrum Niederrhein | |
Mönchengladbach, NRW, Germany, 41061 |
Principal Investigator: | Nadia Harbeck, Prof. Dr. | Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern, Munich, Germany | |
Study Chair: | Ulrike Nitz, Prof. Dr. | Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | West German Study Group |
ClinicalTrials.gov Identifier: | NCT01779206 |
Other Study ID Numbers: |
WSG-AM06 / ADAPT HR+/HER2- |
First Posted: | January 30, 2013 Key Record Dates |
Last Update Posted: | February 7, 2020 |
Last Verified: | February 2020 |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Docetaxel Cyclophosphamide Epirubicin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |