Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00295893
First received: February 23, 2006
Last updated: July 10, 2014
Last verified: July 2014

February 23, 2006
July 10, 2014
September 2005
January 2015   (final data collection date for primary outcome measure)
  • Complete response rate [ Time Frame: At the time of surgery within 4 weeks of the end of chemotherapy ] [ Designated as safety issue: No ]
  • Feasibility [ Time Frame: At the time of surgery within 4 weeks of the end of chemotherapy ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00295893 on ClinicalTrials.gov Archive Site
Quality of life and neuropathy assessment of prognostic and predictive markers as measured by FACT exploratory methods at 1 year [ Time Frame: 1 year post treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer
Randomized Phase II Study of Docetaxel, Adriamycin, and Cytoxan (TAC) Versus Adriamycin/Cytoxan, Followed by Abraxane/Carboplatin (ACAC) +/- Trastuzumab as Neoadjuvant Therapy for Patients With Stage II-III Breast Cancer

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy with or without trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.

PURPOSE: This randomized phase II trial is comparing two different regimens of combination chemotherapy given together with or without trastuzumab to see how well they work in treating patients with stage II or stage III breast cancer.

OBJECTIVES:

Primary

  • Compare 2 neoadjuvant chemotherapy regimens (docetaxel, doxorubicin hydrochloride, and cyclophosphamide [TAC] vs doxorubicin and cyclophosphamide followed by paclitaxel and carboplatin [ACAC]), in terms of toxicities and effectiveness as defined by the pathological complete remission rate, in patients with non HER2/neu overexpressing stage II or III breast cancer.
  • Evaluate the probability of achieving a pathological complete remission when adding trastuzumab (Herceptin®) to ACAC in the subset of patients with HER2/neu overexpressing stage II or III breast cancer.

Secondary

  • Identify prognostic and predictive markers of outcome, recurrence, and targets of therapy.

OUTLINE: This is a randomized study. Patients with non HER2/neu overexpressing tumors are randomized to 1 of 2 treatment arms. Patients with HER2/neu overexpressing tumors are assigned to arm III.

  • Arm I: Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.
  • Arm II: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.
  • Arm III: Patients receive chemotherapy as in arm II. They also receive trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.

Within 4 weeks after completion of chemotherapy with or without trastuzumab (Herceptin®), all patients undergo surgery.

PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Biological: trastuzumab
    Given IV
  • Drug: carboplatin
    Given IV
  • Drug: cyclophosphamide
    Given IV
  • Drug: docetaxel
    Given IV
  • Drug: doxorubicin hydrochloride
    Given IV
  • Drug: paclitaxel
    Given IV
  • Active Comparator: Arm I
    Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.
    Interventions:
    • Drug: carboplatin
    • Drug: cyclophosphamide
    • Drug: docetaxel
    • Drug: doxorubicin hydrochloride
    • Drug: paclitaxel
  • Experimental: Arm II
    Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.
    Interventions:
    • Drug: carboplatin
    • Drug: cyclophosphamide
    • Drug: doxorubicin hydrochloride
    • Drug: paclitaxel
  • Experimental: Arm III
    Patients receive chemotherapy as in arm II. They also receive trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.
    Interventions:
    • Biological: trastuzumab
    • Drug: carboplatin
    • Drug: cyclophosphamide
    • Drug: doxorubicin hydrochloride
    • Drug: paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
105
Not Provided
January 2015   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically proven infiltrating ductal or lobular breast carcinoma

    • Stage II or III disease
    • Inflammatory breast cancer allowed
  • Hormone-receptor status not specified

PATIENT CHARACTERISTICS:

  • ECOG performance status < 2
  • Male or female
  • Menopausal status not specified (for female patients)
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin normal (except for patient's with Gilbert's disease)
  • Creatinine ≤ 1.2 mg/dL
  • Creatinine clearance ≥ 70 mL/min
  • Ejection fraction ≥ 50% on MUGA
  • No neuropathy ≥ grade 1
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception
  • No prior malignant disease within the past 5 years, excluding:

    • Squamous cell or basal cell skin carcinoma
    • Stage I or in situ cervical carcinoma
  • No noninvasive (in situ) breast carcinoma within the past 5 years

PRIOR CONCURRENT THERAPY:

  • At least 5 years since prior antiestrogen treatment for any indication other than breast cancer prevention (tamoxifen, raloxifene, or an aromatase inhibitor)
  • No prior radiotherapy to the chest wall
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00295893
05015, P30CA033572, CDR0000455631
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Not Provided
City of Hope Medical Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP