Status:
COMPLETED
A Prospective, Multicenter, Open-label 12 Week Neoadjuvant Phase II Trial Optimizing Taxane Therapy in Elderly Patients With Low Response
Lead Sponsor:
West German Study Group
Collaborating Sponsors:
Teva Pharmaceuticals USA
Conditions:
Early Primary Breast Cancer
Eligibility:
FEMALE
70+ years
Phase:
PHASE3
Brief Summary
Comparison of pre-surgical Myocet/ Cyclophosphamide (MC) q3w followed by either MC or Paclitaxel - depending on early response assessment by ultrasound or by toxicity for elderly non frail primary bre...
Eligibility Criteria
Inclusion
- General Inclusion Criteria for ADAPT:
- Female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for ADAPT Elderly)
- Candidate for chemotherapy on the basis of conventional criteria
- Histologically confirmed unilateral primary invasive carcinoma of the breast
- Clinical T1 - T4a-c
- 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%
- 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
- Patients must qualify for neoadjuvant treatment
- LVEF \> 50%; LVEF within normal limits of each institution measured by echocardiography and normal ECG (within 42 days prior to chemotherapy)
- Laboratory requirements :
- Leucocytes ≥ 3.5 x 109/L
- Platelets ≥ 100 x 109/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)
- Additional inclusion criteria ADAPT Elderly:
- ≥ 70 years old
- Charlson scale ≤ 2
- HR+/HER2- disease: if RS and sequential testing are available N0-1/RS 12-25/poor response or N0-1/RS ≥26
- All G3 with Ki-67 ≥40% in tumors \>1cm
- All N2
- All TN
- All subtypes
- General Exclusion Criteria for ADAPT:
- 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, 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 clinical trial with any investigational not marketed drug within 30 days prior to study entry (concurrent participation in non-interventional post authorization safety studies not influencing the primary study endpoints is allowed, e.g. WSG PROTROCA for evaluation of primary/secondary G-CSF prophylaxis)
- Male breast cancer
- Sequential breast cancer
- Reasons indicating risk of poor compliance
- Patient not able to consent
- Additional Exclusion Criteria ADAPT Elderly:
- Known polyneuropathy ≥ grade 2
- Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study
- Inadequate organ function (e.g. hepatic impairment, pulmonary disease, etc.)
- Uncompensated cardiac function (current unstable ventricular arrhythmia requiring treatment, history of symptomatic CHF NYHA classes II-IV), history of myocardial infarction or unstable angina pectoris within 12 months of enrollment, history of severe hypertension, CAD - coronary artery disease)
- Severe dyspnea
- Pneumonitis
- Abnormal blood values:
- Thrombocytopenia \> CTCAE grade 1
- Increases in ALT/AST \> CTCAE grade 1
- Hypokalaemia \> CTCAE grade 1
- Neutropenia \> CTCAE grade 1
- Anaemia \> CTCAE grade 1
Exclusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02214381
Start Date
July 1 2014
End Date
January 15 2025
Last Update
February 27 2025
Active Locations (2)
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1
Ev. Krankenhaus Bethesda Brustzentrum Niederrhein
Mönchengladbach, Germany, 41061
2
Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern
Munich, Germany, 81337