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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

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage II breast cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

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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