Cyclophosphamide and Docetaxel or Doxorubicin in Treating Women With Newly Diagnosed Breast Cancer That Can Be Removed by Surgery
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
cyclophosphamide
docetaxel
doxorubicin hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage II breast cancer
Eligibility Criteria
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
Sites / Locations
- Singapore General HospitalRecruiting
- National Cancer Centre - SingaporeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm I
Arm II
Arm Description
Patients receive cyclophosphamide IV and docetaxel IV over 1 hour on day 1.
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1.
Outcomes
Primary Outcome Measures
Pathological complete response rate
Secondary Outcome Measures
Clinical and pathological overall response rate
Toxicity as assessed by NCI CTCAE v3.0
Overall survival
Disease-free survival
Full Information
NCT ID
NCT00801411
First Posted
December 2, 2008
Last Updated
June 16, 2009
Sponsor
National Cancer Centre, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT00801411
Brief Title
Cyclophosphamide and Docetaxel or Doxorubicin in Treating Women With Newly Diagnosed Breast Cancer That Can Be Removed by Surgery
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Cancer Centre, Singapore
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage II breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Randomized
Enrollment
318 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive cyclophosphamide IV and docetaxel IV over 1 hour on day 1.
Arm Title
Arm II
Arm Type
Active Comparator
Arm Description
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1.
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Pathological complete response rate
Secondary Outcome Measure Information:
Title
Clinical and pathological overall response rate
Title
Toxicity as assessed by NCI CTCAE v3.0
Title
Overall survival
Title
Disease-free survival
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wong Nan Soon, MBBS, MRCP, FAMS
Organizational Affiliation
National Cancer Centre, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wong Chow Yin
Phone
65-6222-3322
Facility Name
National Cancer Centre - Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wong Nan Soon, MBBS, MRCP, FAMS
Phone
65-6-436-8088
12. IPD Sharing Statement
Learn more about this trial
Cyclophosphamide and Docetaxel or Doxorubicin in Treating Women With Newly Diagnosed Breast Cancer That Can Be Removed by Surgery
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