A Prospective, Multicenter, Open-label 12 Week Neoadjuvant Phase II Trial Optimizing Taxane Thera… (NCT02214381) | Clinical Trial Compass
CompletedPhase 3
A Prospective, Multicenter, Open-label 12 Week Neoadjuvant Phase II Trial Optimizing Taxane Therapy in Elderly Patients With Low Response
Germany80 participantsStarted 2014-07
Plain-language 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.
Who can participate
Age range70 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Comparison of pCR rates in patients with early response and no severe toxicity (Group 1) and in other patients (Group 2).