Phase 2
N=189
Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00432172 ↗Enrolled (actual)
189
Serious AEs
16.3%
Results posted
Jul 2019
Primary outcome: Primary: Pathological Response for Basal Group 2 — 16; 14; 5; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Epirubicin (Drug); Cyclophosphamide (Drug); Docetaxel (Drug); Exemestane (Drug); Goserelin (Drug); Carboplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Spanish Breast Cancer Research Group
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathological Response for Basal Group 2 |
16; 14; 5; 11; 11; 8 | — |
| SECONDARY Clinical Response Rate |
31; 23; 32; 36 | — |
| SECONDARY Breast Conservative Surgery Rate |
22; 27; 31; 34; 23; 17 | — |
| SECONDARY Axillary Node Status at the Time of Surgery |
15; 14; 31; 32; 29; 28 | — |
Summary
This is an open-label study that includes two substudies of random distribution. First,a sample of the primary tumor will be obtained and will be analyzed by an immunohistochemical technique to determine several markers.Depending on the expression of these markers, the patients will be characterize as group 1 (Luminal A phenotype) or group 2 (Basal phenotype) and a random assignment will be performed to standard or experimental treatment.
Eligibility Criteria
Inclusion Criteria
- Written informed consent.
- Breast cancer with histological diagnosis.
- Negative Human Epidermal Growth Factor Receptor 2 (HER2) tumours defined as immunohistochemistry (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 = 60 ml/min.
- Patients able to comply with study treatment and follow-up.
- Negative pregnancy test in the previous 14 days.
Exclusion Criteria
- HER2 positive tumours (defined as IHQ 3+ or positive fluorescence in situ hybridization [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 [NCICTC]).
- 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.
Data sourced from ClinicalTrials.gov (NCT00432172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.