Early Primary Breast Cancer
Conditions
Keywords
breast cancer, elderly
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 breast cancer patients with increased risk of relapse.
Interventions
Sponsors
Teva Pharmaceuticals USA
West German Study Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of pCR rates in patients with early response and no severe toxicity (Group 1) and in other patients (Group 2). | After 5 years of follow-up. |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of febrile neutropenia (FN) after 1 x MC in patients with primary prophylaxis (PP) vs. others. | After 5 years of follow-up. |
| Toxicity in the 4 x MC versus 2 x MC followed 6 x Pac arm as measured by adverse events. | After 5 years of follow-up. |
| Number of pCR in non-responders to MC. | After 5 years of follow-up. |
| G-CSF use in terms of primary or secondary prophylaxis per patient including occurence febrile neutropenia per patient per cycle | After 5 years of follow-up. |
Countries
Germany
Outcome results
None listed