Clinical trial · Interventional

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

Nonrandomized Ph II Study of Multimodality Therapy for Stg IIB, IIIA/B, or Stg IV Breast Cancer w/4 Cycles of Adriamycin and Cytoxan (AC),Followed by 12 Weeks of Paclitaxel w/ or w/o Herceptin Followed by Local Therapy Followed by Wkly Herceptin or no Additional Therapy

NCT00006110CI-TRIAL-00028841NRRcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

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 (5)

Intervention	Type	Mapped drug	Match
conventional surgery	Procedure	—	UNRESOLVED
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
doxorubicin hydrochloride	Drug	Doxorubicin	ALIAS
paclitaxel	Drug	Paclitaxel	ALIAS
trastuzumab	Biological	Trastuzumab	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Neo-adjuvant Herceptin with or without radiation
description
Chemotherapy followed by Taxol plus Herceptin followed by surgery followed by radiation (or no radiation) followed by additional Herceptin
interventionNames
1. Biological: trastuzumab
2. Drug: cyclophosphamide
3. Drug: doxorubicin hydrochloride
4. Drug: paclitaxel
5. Procedure: conventional surgery
type
EXPERIMENTAL
label
Non-Herceptin with or without radiation
description
Chemotherapy followed by Taxol followed by surgery followed by radiation (or no radiation)
interventionNames
1. Drug: cyclophosphamide
2. Drug: doxorubicin hydrochloride
3. Drug: paclitaxel
4. Procedure: conventional surgery

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 1 Year
Maximum age: 120 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Dec 1, 1998
Primary completion: Mar 1, 2012
Completion: Apr 1, 2013
First posted: Jan 27, 2003
Last update posted: Jul 31, 2017
Results first posted: Jul 31, 2017
Enrollment: 82 (actual)
Lead sponsor: UNC Lineberger Comprehensive Cancer Center OTHER
Keywords: stage II breast cancer, stage IV breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, inflammatory breast cancer

Data updated 22 days agoSource updated Jul 31, 2017source: clinicaltrials

Locations

Locations by country (2)

Country	Sites	Recruiting
United States	2	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.