"A Randomized Multicenter Phase II Trial to Evaluate the Effectiveness of Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients"
18 Years
70 Years
Female
Breast Cancer
Trial Information
"A Randomized Multicenter Phase II Trial to Evaluate the Effectiveness of Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients"
Group 1 (Luminal A):
- Standard treatment: EC x 4 -> Tx4
- Selective treatment: Postmenopausic patients: exemestane x 6 months;
Premenopausic Patients: goserelin x 6 months + exemestane x 6 months
Group 2 (Basal):
- Standard treatment: EC x 4 -> Tx4
- Selective treatment: EC x 4 -> CDPT x 4
Inclusion Criteria:
- Written informed consent.
- Breast cancer with histological diagnosis.
- Negative HER2neu tumours(defined as IHQ 0,1+).
- No evidence of suspicion of metastatic disease.
- Age >= 18 years old.
- Performance status (Karnofsky index) >= 80 (ECOG 0,1).
- Adequate cardiac function by ECG in the previous 12 weeks.
- Hematology: neutrophils >= 1,5 x10^9/l; platelets >= 100 x10^9/l; hemoglobin >= 10
g/dl.
- Adequate hepatic function: total bilirubin <= 1x upper normal limit (UNL); SGOT and
SGPT <= 2.5xUNL; alkaline phosphatase <= 2.5xUNL.
- Adequate renal function: creatinine <= 1xUNL; creatinine clearance >= 60 ml/min.
- Patients able to comply with study treatment and follow-up.
- Negative pregnancy test in the previous 14 days.
Exclusion Criteria:
- HER2neu positive tumours (defined as IHQ 3+ or positive FISH).
- Prior systemic therapy for breast cancer (immunotherapy, hormonotherapy,
chemotherapy).
- Prior treatment with anthracyclines or taxanes (paclitaxel, docetaxel) for any
previous malignancy.
- Prior radiotherapy for breast cancer.
- Bilateral invasive breast cancer.
- Pregnant or lactating women.
- Previous grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute
Common Toxicity Criteria [NCI CTC]).
- Other serious comorbidities: congestive heart failure or unstable angina; prior
history of myocardial infarction in previous year; uncontrolled hypertension (HT);
high risk arrhythmias; history of significant neurological or psychiatric disorders;
uncontrolled active infection; active peptic ulcer; unstable diabetes mellitus;
dyspnea at rest; or chronic therapy with oxygen.
- Previous or current history of neoplasms different from breast cancer, except for
skin carcinoma, cervical in situ carcinoma, or any other tumor curatively treated and
without recurrence in the last 10 years; ductal in situ carcinoma in the same breast;
lobular in situ carcinoma.
- Chronic treatment with corticosteroids.
- Contraindications for administration of corticosteroids.
- Concomitant treatment with other therapy for cancer.
- Males.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Description:
Pathological response (basal group): pathological response will be assessed after surgery, according to the scale of Miller & Payne. Clinical Response: will be evaluated the clinical response to treatment according to the model established by the RECIST Group. (Response Evaluation Criteria in Solid Tumors).
Outcome Time Frame:
After surgey.
Safety Issue:
No
Principal Investigator
Antonio Antón, MD., PhD.
Investigator Role:
Study Chair
Investigator Affiliation:
Spanish Breast Cancer Research Group (GEICAM)
Authority:
Spain: Spanish Agency of Medicines
Study ID:
GEICAM/2006-03
NCT ID:
NCT00432172
Start Date:
September 2007
Completion Date:
July 2013
Related Keywords:
- Breast Cancer
- Her2neu negative breast cancer.
- Neoadjuvant treatment.
- Breast Neoplasms
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