Clinical trial · Interventional

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

NCT00295893CI-TRIAL-00095813active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
Carboplatin	Drug	Carboplatin	ALIAS
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
docetaxel	Drug	Docetaxel	ALIAS
doxorubicin hydrochloride	Drug	Doxorubicin	ALIAS
Paclitaxel	Drug	Paclitaxel	ALIAS
Trastuzumab	Biological	Trastuzumab	ALIAS

Design

Arms and outcomes

Arms (3)

type
ACTIVE_COMPARATOR
label
Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide
description
Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.
interventionNames
1. Drug: cyclophosphamide
2. Drug: docetaxel
3. Drug: doxorubicin hydrochloride
type
EXPERIMENTAL
label
Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin
description
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.
interventionNames
1. Drug: cyclophosphamide
2. Drug: doxorubicin hydrochloride
3. Drug: Carboplatin

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 120 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Sep 27, 2005
Primary completion: Dec 30, 2013
Completion: Jul 16, 2027
First posted: Feb 24, 2006
Last update posted: Sep 24, 2026
Results first posted: Mar 14, 2023
Enrollment: 121 (actual)
Lead sponsor: City of Hope Medical Center OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: inflammatory breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, male breast cancer, Paget disease of the breast with invasive ductal carcinoma, invasive ductal breast carcinoma with predominant intraductal component, invasive ductal breast carcinoma, medullary ductal breast carcinoma with lymphocytic infiltrate, comedo ductal breast carcinoma, invasive lobular breast carcinoma with predominant in situ component, invasive lobular breast carcinoma, mucinous ductal breast carcinoma, papillary ductal breast carcinoma, tubular ductal breast carcinoma

Data updated 4 days agoSource updated Sep 24, 2026source: clinicaltrials

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