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

NCT01779206 | Completed Phase 2 DMC

• 1 other identifier: WSG-AM06 / ADAPT HR+/HER2-
• Study Type: interventional
• Target: 4,936
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

  3 Years

Secondary Outcomes (1)

• Overall survival

  3 Years

Study Arms (2)

Anthracycline - Taxane

ACTIVE COMPARATOR

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

Taxane - Anthracycline

EXPERIMENTAL

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

Interventions

Epirubicin DRUG

Anthracycline - Taxane; Taxane - Anthracycline

Cyclophosphamide DRUG

Anthracycline - Taxane; Taxane - Anthracycline

Docetaxel DRUG

Anthracycline - Taxane; Taxane - Anthracycline

Paclitaxel DRUG

Anthracycline - Taxane; Taxane - Anthracycline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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:

Sponsors & Collaborators

• West German Study Group: lead

Study Sites (2)

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

Munich, Bavaria, 81377, Germany

Location

Ev. Krankenhaus Bethesda Brustzentrum Niederrhein

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Location

Related Publications (7)

• 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.

  PMID: 23958221 BACKGROUND

• 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.

  PMID: 40705465 DERIVED

• 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.

  PMID: 37062416 DERIVED

• 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.

  PMID: 36809046 DERIVED

• 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.

  PMID: 35404683 DERIVED

• 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.

  PMID: 33736679 DERIVED

• 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.

  PMID: 33281950 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Epirubicin; Cyclophosphamide; Docetaxel; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Nadia Harbeck, Prof. Dr.

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

  PRINCIPAL INVESTIGATOR

• Ulrike Nitz, Prof. Dr.

  Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: January 30, 2013
• Study Start: May 1, 2012
• Primary Completion: September 1, 2019
• Study Completion: January 15, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

DE (2)