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

Sponsor:

Information provided by (Responsible Party):

West German Study Group

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Epirubicin Drug: Cyclophosphamide Drug: Docetaxel Drug: Paclitaxel	Phase 2 Phase 3

Study Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Breast cancer

MedlinePlus related topics: Breast Cancer

U.S. FDA Resources

Arms and Interventions

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.	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.	Drug: Epirubicin Drug: Cyclophosphamide Drug: Docetaxel Drug: Paclitaxel

Outcome Measures

Primary Outcome Measures :

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 ]

Secondary Outcome Measures :

Overall survival [ Time Frame: 3 Years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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:

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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Germany
Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern
Munich, Bavaria, Germany, 81377
Ev. Krankenhaus Bethesda Brustzentrum Niederrhein
Mönchengladbach, NRW, Germany, 41061

Sponsors and Collaborators

West German Study Group

Investigators

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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

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nitz UA, Gluz O, Kümmel S, Christgen M, Braun M, Aktas B, Lüdtke-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, Gräser M, Würstlein 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, Würstlein R, Culemann R, Eulenburg C, Adams J, Nitzsche H, Prange A, Kümmel 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, Lüdtke-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.

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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

Additional relevant MeSH terms:

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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

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