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Cyclophosphamide and Docetaxel or Doxorubicin in Treating Women With Newly Diagnosed Breast Cancer That Can Be Removed by Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00801411
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : December 3, 2008
Last Update Posted : June 17, 2009
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Phase 2

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 318 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm I
Patients receive cyclophosphamide IV and docetaxel IV over 1 hour on day 1.
Drug: cyclophosphamide
Given IV

Drug: docetaxel
Given IV

Active Comparator: Arm II
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1.
Drug: cyclophosphamide
Given IV

Drug: doxorubicin hydrochloride
Given IV

Primary Outcome Measures :
  1. Pathological complete response rate

Secondary Outcome Measures :
  1. Clinical and pathological overall response rate
  2. Toxicity as assessed by NCI CTCAE v3.0
  3. Overall survival
  4. Disease-free survival

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00801411

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Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Wong Chow Yin    65-6222-3322      
National Cancer Centre - Singapore Recruiting
Singapore, Singapore, 169610
Contact: Wong Nan Soon, MBBS, MRCP, FAMS    65-6-436-8088      
Sponsors and Collaborators
National Cancer Centre, Singapore
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Principal Investigator: Wong Nan Soon, MBBS, MRCP, FAMS National Cancer Centre, Singapore

Layout table for additonal information Identifier: NCT00801411    
Other Study ID Numbers: CDR0000624374
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: June 17, 2009
Last Verified: June 2009
Keywords provided by National Cancer Institute (NCI):
stage II breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors