Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients
NCT00432172
ABOUT THIS STUDY
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- 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 <= 1x Upper Normal Limit (UNL); Aspartate aminotransferase (AST) (SGOT) and Alanine aminotransferase (ALT) (SGPT) <= 2.5 x UNL; alkaline phosphatase <= 2.5 x UNL.
- Adequate renal function: creatinine <= 1 x UNL; creatinine clearance >= 60 ml/min.
- Patients able to comply with study treatment and follow-up.
- Negative pregnancy test in the previous 14 days.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients | |||
Official Title ICMJE | "A Randomized Multicenter Phase II Trial to Evaluate the Effectiveness of Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients" | |||
Brief 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. | |||
Detailed Description | Group 1 (Luminal A):
EC x 4 -> D x 4
Group 2 (Basal):
EC x 4 -> DCb x 4 | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Breast Cancer | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 189 | |||
Original Enrollment ICMJE | 188 | |||
Actual Study Completion Date ICMJE | September 1, 2010 | |||
Actual Primary Completion Date | September 1, 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Spain | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00432172 | |||
Other Study ID Numbers ICMJE | GEICAM/2006-03 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Spanish Breast Cancer Research Group | |||
Study Sponsor ICMJE | Spanish Breast Cancer Research Group | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | Spanish Breast Cancer Research Group | |||
Verification Date | May 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |