Neoadjuvant Endostatin and Chemotherapy for Breast Cancer
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Purpose
This study was designed to determine the efficacy and safety of neoadjuvant docetaxel and epirubicin (DE) with or without human recombinant endostatin (endostar) for breast cancer patients. The hypothesis of this protocol is that a combined angiogenesis inhibiting therapy to chemotherapy could further enhance the cytotoxic activity in breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: docetaxel and epirubicin Drug: docetaxel and epirubicin plus endostatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Neoadjuvant Recombinant Human Endostatin, Docetaxel and Epirubicin as First-line Therapy in Patients With Breast Cancer |
- clinical/pathological response [ Time Frame: one year ] [ Designated as safety issue: No ]
- safety and tolerability [ Time Frame: one year ] [ Designated as safety issue: Yes ]
| Enrollment: | 69 |
| Study Start Date: | February 2008 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: chemotherapy
neoadjuvant therapy with 3 cycles of Docetaxel and Epirubicin
|
Drug: docetaxel and epirubicin
docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 60 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, totally 3 cycles
Other Names:
|
|
Experimental: chemotherapy plus endostatin
neoadjuvant therapy with 3 cycles of Docetaxel and Epirubicin plus endostatin
|
Drug: docetaxel and epirubicin plus endostatin
docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 60 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; endostatin 7.5mg/m2, IV (in the vein) on 1st to 14th days of each 21 day cycle; every 3 weeks, totally 3 cycles
Other Name: recombinant human endostatin, Simcere Co. China
|
Detailed Description:
This is an open labelled, prospective, randomized, phase II clinical trial. A total of 60 patients with core-biopsy confirmed breast cancer, stage ⅡA to ⅢC, and to be treated with neoadjuvant systemic therapy are eligible for entry into this study. Patients will be allocated randomly to two groups to receive either 3 cycles of neoadjuvant DE and endostar or 3 cycles of neoadjuvant DE. All cases receive mammography, contrast-enhanced ultrasound (CEUS), magnetic resonance angiography (MRA), and positron emission tomography (PET) scanning pre- and post-neoadjuvant therapy, and then undergo surgical resection. The primary endpoint is clinical/pathological response. The secondary endpoint is (1) the safety and tolerability of the regimens, (2) the role of mammography, CEUS, MRA and PET for response evaluation, and (3) angiogenic profile and biological information involved in tumor response.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)
- Stage ⅡA-ⅢC
- Age 18-70
- ECOG performance status 0-2
- No evidence of distant metastasis
- No previous therapy
- Normal hematologic function
- left ventricular ejection fraction greater than 50 percent
- No abnormality of renal or liver function
- Written informed consent
Exclusion Criteria:
- With allergic constitution or possible allergic reflection to drugs to be used in this study
- Any concurrent uncontrolled medical or psychiatric disorder
- History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease.
- History of bleeding diathesis
- Being pregnant or nursing
Contacts and Locations| China, Shaanxi | |
| Xijing Hospital, Fourth Military Medical University | |
| Xi'an, Shaanxi, China, 710032 | |
| Study Director: | Ling Wang, MD | Xijing Hospital, Fourth Military Medical University |
| Study Chair: | Jianghao Chen, MD, PhD | Xijing Hospital, Fourth Military Medical University |
More Information
Additional Information:
Publications:
| Responsible Party: | Dai-Ming Fan, Principal of Fourth Military Medical University, Fourth Military Medical University |
| ClinicalTrials.gov Identifier: | NCT00604435 History of Changes |
| Other Study ID Numbers: | Endostar B-01, XOBCR01 |
| Study First Received: | January 16, 2008 |
| Last Updated: | January 18, 2010 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Xijing Hospital:
|
breast cancer neoadjuvant chemotherapy docetaxel epirubicin |
recombinant human endostatin (endostar) chemotherapy endostatin |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Epirubicin Docetaxel Endostatins Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013