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

Phase 2

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Drug: nab-Paclitaxel; Drug: Carboplatin; Drug: Gemcitabine

• Registration Number: NCT01815242
• Lead Sponsor: West German Study Group

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-18
• Study First Submitted QC: 2013-03-18
• Study First Posted: 2013-03-21
• Study Start: 2013-06
• Primary Completion: 2015-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 336

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	nab-Paclitaxel	nab-Paclitaxel + gemcitabine
Arm B	nab-Paclitaxel	nab-Paclitaxel + carboplatin
Arm B	Carboplatin	nab-Paclitaxel + carboplatin
Arm A	Gemcitabine	nab-Paclitaxel + gemcitabine

Primary Outcome Measures

Name	Time	Method
Comparison: pCR in nab-paclitaxel/carboplatin vs. nab-paclitaxel/gemcitabine	After 12 weeks of therapy	pCR will be measured after 12 weeks of randomized treatment.
Comparison: pCR in responders vs. non-responders	After 12 weeks of therapy	pCR will be measured after 12 weeks of randomized treatment.

Trial Locations

Locations (1)

Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany; 🇩🇪 Moenchengladbach, Germany