ADAPT - Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer
NCT ID: NCT01779206
Last Updated: 2025-04-08
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
4936 participants
INTERVENTIONAL
2012-05-31
2025-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Epirubicin
Cyclophosphamide
Docetaxel
Paclitaxel
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.
Epirubicin
Cyclophosphamide
Docetaxel
Paclitaxel
Interventions
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Epirubicin
Cyclophosphamide
Docetaxel
Paclitaxel
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
18 Years
FEMALE
No
Sponsors
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West German Study Group
OTHER
Responsible Party
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Principal Investigators
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Nadia Harbeck, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern, Munich, Germany
Ulrike Nitz, Prof. Dr.
Role: STUDY_CHAIR
Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany
Locations
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Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern
Munich, Bavaria, Germany
Ev. Krankenhaus Bethesda Brustzentrum Niederrhein
Mönchengladbach, North Rhine-Westphalia, Germany
Countries
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References
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Hofmann D, Nitz U, Gluz O, Kates RE, Schinkoethe T, Staib P, Harbeck N. WSG ADAPT - adjuvant dynamic marker-adjusted personalized therapy trial optimizing risk assessment and therapy response prediction in early breast cancer: study protocol for a prospective, multi-center, controlled, non-blinded, randomized, investigator initiated phase II/III trial. Trials. 2013 Aug 19;14:261. doi: 10.1186/1745-6215-14-261.
Zhang G, Jurinovic V, Bartels S, Christgen M, Christgen H, Kandt LD, Mishieva L, Ni H, Raap M, Klein J, Katzke AL, Hofmann W, Steinemann D, Kates RE, Gluz O, Graeser M, Kummel S, Nitz U, Plass C, Lehmann U, Zu Eulenburg C, Mansmann U, Gerhauser C, Harbeck N, Kreipe HH. A predictive endocrine resistance index accurately stratifies luminal breast cancer treatment responders and nonresponders. J Clin Invest. 2025 Jul 24;135(19):e177813. doi: 10.1172/JCI177813. eCollection 2025 Oct 1.
Gluz O, Kuemmel S, Nitz U, Braun M, Ludtke-Heckenkamp K, von Schumann R, Darsow M, Forstbauer H, Potenberg J, Uleer C, Grischke EM, Aktas B, Schumacher C, Zu Eulenburg C, Kates R, Jozwiak K, Graeser M, Wuerstlein R, Baehner R, Christgen M, Kreipe HH, Harbeck N. Nab-paclitaxel weekly versus dose-dense solvent-based paclitaxel followed by dose-dense epirubicin plus cyclophosphamide in high-risk HR+/HER2- early breast cancer: results from the neoadjuvant part of the WSG-ADAPT-HR+/HER2- trial. Ann Oncol. 2023 Jun;34(6):531-542. doi: 10.1016/j.annonc.2023.04.002. Epub 2023 Apr 14.
Harbeck N, Nitz UA, Christgen M, Kummel S, Braun M, Schumacher C, Potenberg J, Tio J, Aktas B, Forstbauer H, Grischke EM, Scheffen I, Malter W, von Schumann R, Just M, Zu Eulenburg C, Biehl C, Kolberg-Liedtke C, Deurloo R, de Haas S, Jozwiak K, Hauptmann M, Kates R, Graeser M, Wuerstlein R, Kreipe HH, Gluz O; WSG-ADAPT investigators. De-Escalated Neoadjuvant Trastuzumab-Emtansine With or Without Endocrine Therapy Versus Trastuzumab With Endocrine Therapy in HR+/HER2+ Early Breast Cancer: 5-Year Survival in the WSG-ADAPT-TP Trial. J Clin Oncol. 2023 Aug 1;41(22):3796-3804. doi: 10.1200/JCO.22.01816. Epub 2023 Feb 21.
Nitz UA, Gluz O, Kummel S, Christgen M, Braun M, Aktas B, Ludtke-Heckenkamp K, Forstbauer H, Grischke EM, Schumacher C, Darsow M, Krauss K, Nuding B, Thill M, Potenberg J, Uleer C, Warm M, Fischer HH, Malter W, Hauptmann M, Kates RE, Graser M, Wurstlein R, Shak S, Baehner F, Kreipe HH, Harbeck N. Endocrine Therapy Response and 21-Gene Expression Assay for Therapy Guidance in HR+/HER2- Early Breast Cancer. J Clin Oncol. 2022 Aug 10;40(23):2557-2567. doi: 10.1200/JCO.21.02759. Epub 2022 Apr 11.
Graeser M, Schrading S, Gluz O, Strobel K, Herzog C, Umutlu L, Frydrychowicz A, Rjosk-Dendorfer D, Wurstlein R, Culemann R, Eulenburg C, Adams J, Nitzsche H, Prange A, Kummel S, Grischke EM, Forstbauer H, Braun M, Potenberg J, von Schumann R, Aktas B, Kolberg-Liedtke C, Harbeck N, Kuhl CK, Nitz U. Magnetic resonance imaging and ultrasound for prediction of residual tumor size in early breast cancer within the ADAPT subtrials. Breast Cancer Res. 2021 Mar 18;23(1):36. doi: 10.1186/s13058-021-01413-y.
Nitz U, Gluz O, Kreipe HH, Christgen M, Kuemmel S, Baehner FL, Shak S, Aktas B, Braun M, Ludtke-Heckenkamp K, Forstbauer H, Grischke EM, Nuding B, Darsow M, Schumacher C, Krauss K, Malter W, Thill M, Warm M, Wuerstlein R, Kates RE, Harbeck N. The run-in phase of the prospective WSG-ADAPT HR+/HER2- trial demonstrates the feasibility of a study design combining static and dynamic biomarker assessments for individualized therapy in early breast cancer. Ther Adv Med Oncol. 2020 Nov 23;12:1758835920973130. doi: 10.1177/1758835920973130. eCollection 2020.
Other Identifiers
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WSG-AM06 / ADAPT HR+/HER2-
Identifier Type: -
Identifier Source: org_study_id
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