- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00801411
Cyclophosphamide and Docetaxel or Doxorubicin in Treating Women With Newly Diagnosed Breast Cancer That Can Be Removed by Surgery
A Randomised Phase 2 Study of Neoadjuvant Docetaxel and Cyclophosphamide Compared to Doxorubicin and Cyclophosphamide in Operable Node Negative Breast Cancer With Normal Topoisomerase IIα Expression
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, docetaxel, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which chemotherapy regimen is more effective in treating breast cancer.
PURPOSE: This randomized phase II trial is studying cyclophosphamide given together with docetaxel to see how well it works compared with cyclophosphamide given together with doxorubicin in treating women with newly diagnosed breast cancer that can be removed by surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- To evaluate tumor pathological complete response rate after neoadjuvant cyclophosphamide in combination with docetaxel vs doxorubicin hydrochloride in women with operable clinically node-negative breast cancer and normal topoisomerase IIα expression.
Secondary
- To assess tumor clinical and pathological overall response rates in patients treated with these regimens.
- To assess the safety and toxicity of these regimens.
- To assess disease-free survival and overall survival of these patients.
- To assess the efficacy of short-course (3 days) filgrastim (G-CSF) as primary and secondary prophylaxis against febrile neutropenia in patients receiving docetaxel and cyclophosphamide.
OUTLINE: This is a multicenter study.
Patients are stratified according to hormone receptor status (estrogen receptor [ER]- or progesterone receptor [PR]-positive vs ER- and PR-negative) and T stage (T2 vs T3). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cyclophosphamide IV and docetaxel IV over 1 hour on day 1.
- Arm II: Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1.
In both arms, treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of neoadjuvant chemotherapy, all patients undergo surgery.
Tumor specimens obtained prior to neoadjuvant chemotherapy are analyzed for topoisomerase IIα gene and protein expression by IHC and FISH. Tissue samples are also collected at surgery for future studies.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 169608
- Recruiting
- Singapore General Hospital
-
Contact:
- Wong Chow Yin
- Phone Number: 65-6222-3322
-
Singapore, Singapore, 169610
- Recruiting
- National Cancer Centre - Singapore
-
Contact:
- Wong Nan Soon, MBBS, MRCP, FAMS
- Phone Number: 65-6-436-8088
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
- Newly diagnosed disease
- Operable disease
Must have clinical T2 (> 2cm) or T3 (> 5 cm) primary tumors with no clinical lymph node involvement (N0)
- No clinical T4 lesion (e.g., peau d'orange, skin ulceration, satellite nodules, or inflammatory breast cancer)
- No evidence of metastatic disease
- Known hormone receptor status
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%)
- Life expectancy > 10 years
- Leukocytes ≥ 3,000/mm³
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine normal or creatinine clearance ≥ 40 mL/min
- Normal cardiac ejection fraction, defined as ≥ 50% by MUGA scan or 2D-ECHO
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel or other agents used in this study
- No history of pre-existing peripheral neuropathy
No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
- No prior malignancies except curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
- No other concurrent investigational or commercial agents or therapies with the intent to treat the patient's malignancy
- No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, surgery for cancer, or experimental medications
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent antitumor therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
Patients receive cyclophosphamide IV and docetaxel IV over 1 hour on day 1.
|
Given IV
Given IV
|
Active Comparator: Arm II
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1.
|
Given IV
Given IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Pathological complete response rate
|
Secondary Outcome Measures
Outcome Measure |
---|
Overall survival
|
Disease-free survival
|
Toxicity as assessed by NCI CTCAE v3.0
|
Clinical and pathological overall response rate
|
Collaborators and Investigators
Investigators
- Principal Investigator: Wong Nan Soon, MBBS, MRCP, FAMS, National Cancer Centre, Singapore
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Docetaxel
- Cyclophosphamide
- Doxorubicin
- Liposomal doxorubicin
Other Study ID Numbers
- CDR0000624374
- SINGAPORE-NCC0705
- SANOFI-AVENTIS-NCC0705
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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