Status:
WITHDRAWN
Cyclophosphamide and Docetaxel Every 3 Weeks as Neoadjuvant Therapy in Locally Advanced Breast Cancer
Lead Sponsor:
Tufts Medical Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The standard therapy for patients who have locally advanced breast cancer is to receive chemotherapy before surgical removal of tumor. This is called neoadjuvant chemotherapy (NAC). Chemotherapy is us...
Detailed Description
This is a single-arm, open-label phase II study of cyclophosphamide and docetaxel/taxotere (TC) every 3 weeks in Her2 (-) subjects with locally advanced breast cancer. It is designed to assess (1) the...
Eligibility Criteria
Inclusion
- Women 18 years of age or older
- Histologically documented adenocarcinoma of the breast, with T2 (T\>2.0 cm) N0 or more advanced disease.
- No evidence of metastatic disease.
- Disease must be clinically or radio-graphically measurable or evaluable.
- Incisional or core needle biopsy, yielding sufficient tissue for histologic confirmation of adenocarcinoma, hormone receptor analysis and Her2 testing; and Tiam-1 expression.
- Subjects may have received no prior chemotherapy for breast cancer. Subjects may have received up to 3 months of neoadjuvant hormonal therapy, provided they have been re-staged and are still eligible for this study, and have been off hormonal therapy at least 48 hours.
- Subject must be Her-2 negative.
- Performance status 0-1 by the ECOG scale.
- Baseline laboratory values must be as follows: Absolute granulocyte count: greater than 1400/cells/ml; Platelets: greater than 100,000 cells/ml; Total bilirubin: less than 1.5 mg/dl; Serum ALT: less than 2.5 x institutional upper normal limit; Creatinine: less than 1.6mg/dl; Hemoglobin: greater than 9.0g/dl
- Subjects must be nonpregnant and nonlactating. Subjects of childbearing potential must utilize an effective method of contraception during the study.
Exclusion
- Subjects who have received chemotherapy or more than 3 months of neoadjuvant hormone therapy for this cancer.
- Subjects with metastatic disease (disease beyond the breast, axillary nodes and ipsilateral supraclavicular nodes) or inflammatory breast cancer (T4d).
- Subjects with other active cancers, except non-melanoma skin cancers
- Subjects with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
- Dementia or significantly altered mental status that would prohibit comprehension of or giving of informed consent.
- Pregnant or breast-feeding women; sexually active, pre-menopausal women not willing to use adequate methods of birth control.
- Subjects who are Her 2 neu positive are excluded.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01229605
Start Date
October 1 2010
End Date
December 1 2011
Last Update
December 12 2011
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