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

NCT01815242 | Completed Phase 2 DMC

• 1 other identifier: WSG-AM06 / ADAPT TN
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

Brief Summary

The trial will evaluate the optimal treatment with nab-paclitaxel in combination with either carboplatin or gemcitabine for patients with triple negative breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Comparison: pCR in nab-paclitaxel/carboplatin vs. nab-paclitaxel/gemcitabine

  pCR will be measured after 12 weeks of randomized treatment.

  After 12 weeks of therapy

• Comparison: pCR in responders vs. non-responders

  pCR will be measured after 12 weeks of randomized treatment.

  After 12 weeks of therapy

Study Arms (2)

Arm A

EXPERIMENTAL

nab-Paclitaxel + gemcitabine

Drug: nab-Paclitaxel; Drug: Gemcitabine

Arm B

EXPERIMENTAL

nab-Paclitaxel + carboplatin

Drug: nab-Paclitaxel; Drug: Carboplatin

Interventions

nab-Paclitaxel DRUG

Arm A; Arm B

Gemcitabine DRUG

Arm A

Carboplatin DRUG

Arm B

Eligibility Criteria

• Age: 18 Years - 75 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 10\^9/L
• Platelets \>= 100 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
• Celgene: collaborator

Study Sites (1)

Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany

Mönchengladbach, 41061, Germany

Location

Related Publications (6)

• 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

• Korbie D, Stirzaker C, Gluz O, Zu Eulenburg C, Nitz U, Christgen M, Kuemmel S, Grischke EM, Forstbauer H, Braun M, Warm M, Hackmann J, Uleer C, Aktas B, Schumacher C, Wuerstlein R, Pelz E, Kreipe HH, Clark SJ, Trau M, Graeser M, Harbeck N. Immunomodulatory gene networks predict treatment response and survival to de-escalated, anthracycline-free neoadjuvant chemotherapy in triple-negative breast cancer in the WSG-ADAPT-TN trial. Mol Cancer. 2025 Mar 26;24(1):96. doi: 10.1186/s12943-025-02275-0.

  PMID: 40140821 DERIVED

• Richters L, Gluz O, Weber-Lassalle N, Christgen M, Haverkamp H, Kuemmel S, Kayali M, Kates RE, Grischke EM, Altmuller J, Forstbauer H, Thiele H, Braun M, Warm M, Ossowski A, Wuerstlein R, Ernst C, Graeser M, Linn SC, Nitz U, Hauke J, Kreipe HH, Schmutzler RK, Hahnen E, Harbeck N. Genetic Alterations, Therapy Response, and Survival Among Patients With Triple-Negative Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2461639. doi: 10.1001/jamanetworkopen.2024.61639.

  PMID: 40009381 DERIVED

• Kolberg-Liedtke C, Feuerhake F, Garke M, Christgen M, Kates R, Grischke EM, Forstbauer H, Braun M, Warm M, Hackmann J, Uleer C, Aktas B, Schumacher C, Kuemmel S, Wuerstlein R, Graeser M, Nitz U, Kreipe H, Gluz O, Harbeck N. Impact of stromal tumor-infiltrating lymphocytes (sTILs) on response to neoadjuvant chemotherapy in triple-negative early breast cancer in the WSG-ADAPT TN trial. Breast Cancer Res. 2022 Sep 2;24(1):58. doi: 10.1186/s13058-022-01552-w.

  PMID: 36056374 DERIVED

• Gluz O, Nitz U, Kolberg-Liedtke C, Prat A, Christgen M, Kuemmel S, Mohammadian MP, Gebauer D, Kates R, Pare L, Grischke EM, Forstbauer H, Braun M, Warm M, Hackmann J, Uleer C, Aktas B, Schumacher C, Wuerstlein R, Graeser M, Pelz E, Jozwiak K, Zu Eulenburg C, Kreipe HH, Harbeck N; ADAPT TN investigators. De-escalated Neoadjuvant Chemotherapy in Early Triple-Negative Breast Cancer (TNBC): Impact of Molecular Markers and Final Survival Analysis of the WSG-ADAPT-TN Trial. Clin Cancer Res. 2022 Nov 14;28(22):4995-5003. doi: 10.1158/1078-0432.CCR-22-0482.

  PMID: 35797219 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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Gemcitabine; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

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: March 18, 2013
• First Posted: March 21, 2013
• Study Start: June 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: January 15, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

DE (1)