Phase 2 N=82 Treatment

Multimodality Treatment for Women With Stage II, Stage III, or Stage IV Breast Cancer

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00006110 ↗

Enrolled (actual)

Serious AEs

9.8%

Results posted

Jul 2017

Primary outcome: Primary: Cardiac Toxicity of Weekly Taxol Given With Weekly Herceptin When Delivered Immediately Following Four Cycles of Standard Dose AC. — 1; 8; 3; 11 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: trastuzumab (Biological); cyclophosphamide (Drug); doxorubicin hydrochloride (Drug); paclitaxel (Drug); conventional surgery (Procedure)
Age: Pediatric, Adult, Older Adult · 1+ yrs
Sex: Female
Sponsor: UNC Lineberger Comprehensive Cancer Center
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Cardiac Toxicity of Weekly Taxol Given With Weekly Herceptin When Delivered Immediately Following Four Cycles of Standard Dose AC.	1; 8; 3; 11; 0; 1	—
SECONDARY Overall Response	32; 24	—
SECONDARY Disease-free Survival (DFS) in Patients Receiving and Not Receiving Herceptin®.	69; 60	—

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy, monoclonal antibody therapy, and surgery may be a more effective treatment for breast cancer. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, monoclonal antibody therapy, and surgery in treating women who have stage II, stage III, or stage IV breast cancer.

Eligibility Criteria

Inclusion Criteria

Histologically confirmed stage IIB, IIIA, IIIB, IIIC, or previously untreated stage IV primary carcinoma of the breast
Fine needle aspiration, core needle biopsy, or incisional biopsy allowed
No excisional biopsy
Any of the following:
Tumor size 2, Nodes 1 (T2N1) or tumor size 3 nodes 0 (T3N0)
Any T with N2 (including axillary lymph nodes matted to one another) or N3
Any T4, including inflammatory breast cancer
Adjuvant patients with at least 4 positive lymph nodes and HER-2 overexpressing tumor
Supraclavicular or infraclavicular positive lymph nodes without distant metastases
Distant metastases with measurable disease in breast or lymph nodes
Synchronous bilateral primary breast cancer allowed if the more serious cancer meets entry criteria
Measurable or evaluable disease

PATIENT CHARACTERISTICS:

Age: Not specified

Sex: Female

Menopausal status: Not specified

Performance status: Not specified

Life expectancy: Not specified

Hematopoietic:

White cell count > 3000 / mm3 Platelet count > 100,000 / mm3

Hemoglobin > 9 mg / dl Bilirubin < 1.5 x normal Creatinine < 1.5 x normal left ventricular ejection fraction (LVEF) normal by resting nuclear ventriculogram Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

Exclusions

Prior malignancies except:

Effectively treated squamous cell or basal cell skin cancer Carcinoma in situ of the cervix that has been curatively treated by surgery alone Nonbreast malignancy from which patient has been disease-free for 5 years and is at low risk of recurrence

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00006110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.