Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Positive Breast Cancer

NCT00093795 | Completed Phase 3 Results DMC

• 2 other identifiers: NSABP B-38U10CA012027
• Study Type: interventional
• Target: 4,894
• Locations: 1 country
• Sites: 12

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin , cyclophosphamide, paclitaxel, and gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any remaining tumor cells. PURPOSE: This randomized phase III trial is studying three different combination chemotherapy regimens and comparing how well they work in treating women who have undergone surgery for node-positive breast cancer.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free Survival: Any Recurrence, Contralateral Breast Cancer, Second Primary Cancer, Death From Any Cause Prior to Recurrence or Second Primary Cancer

  The percentage of patients alive and cancer-free.

  5 years

Secondary Outcomes (4)

• Overall Survival

  5 years

• Recurrence-free Interval: Time to First Local, Regional, or Distant Recurrence

  5 years

• Distant Recurrence-free Interval: the Time to Distant Disease Recurrence Only

  5 years

• Toxicity

  30 days after the last dose of study therapy (about 7 months after study entry)

Study Arms (3)

Group 1: TAC X 6

ACTIVE COMPARATOR

Doxorubicin, cyclophosphamide, and docetaxel.

Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Doxorubicin

Group 2: AC X 4 then P X 4

ACTIVE COMPARATOR

Doxorubicin, cyclophosphamide, and paclitaxel

Drug: Cyclophosphamide; Drug: Paclitaxel; Drug: Doxorubicin

Group 3: AC X 4 then PG X 4

EXPERIMENTAL

Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine

Drug: Cyclophosphamide; Drug: Gemcitabine; Drug: Paclitaxel; Drug: Doxorubicin

Interventions

Cyclophosphamide DRUG

Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles

Also known as: C

Group 1: TAC X 6; Group 2: AC X 4 then P X 4; Group 3: AC X 4 then PG X 4

Docetaxel DRUG

75 mg/m2 IV every 21 days for 6 cycles

Also known as: Taxotere, T

Group 1: TAC X 6

Gemcitabine DRUG

2000 mg/m2 IV every 14 days for 4 cycles

Also known as: Gemzar, G

Group 3: AC X 4 then PG X 4

Paclitaxel DRUG

175 mg/m2 IV every 14 days for 4 cycles

Also known as: Taxol, P

Group 2: AC X 4 then P X 4; Group 3: AC X 4 then PG X 4

Doxorubicin DRUG

Group 1: 50 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles

Also known as: A, Adriamycin

Group 1: TAC X 6; Group 2: AC X 4 then P X 4; Group 3: AC X 4 then PG X 4

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must consent to participate in the study and must have signed an approved consent form conforming with federal and institutional guidelines.
• The patient must have a life expectancy of at least 10 years and a Zubrod performance status of 0 or 1. (Comorbid conditions but not the diagnosis of breast cancer should be taken into consideration when determining life expectancy.)
• The interval between the last surgery for breast cancer staging or treatment and randomization must be no more than 84 days.
• The tumor must be invasive carcinoma of the breast on histologic examination.
• All of the following staging criteria must be met:
• By clinical and pathologic evaluation, primary tumor must be T1-3;
• By clinical evaluation, ipsilateral nodes must be cN0, cN1, or cN2a;
• By pathologic evaluation, ipsilateral nodes must be pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b (only if due to microscopic involvement of internal mammary node detected by sentinel lymph node dissection and with more than 3 positive axillary lymph nodes).
• Patients must have an estrogen receptor (ER) analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then progesterone receptor (PgR) analysis must be performed. If ER analysis is positive, PgR analysis is desired, but not mandatory. ("Marginal" or "borderline" results \[i.e., those not definitely negative\] will be considered positive regardless of the methodology used.)
• Patients must have had either a lumpectomy or a total mastectomy. Patients must have completed one of the following procedures for evaluation of pathologic nodal status.
• Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes (This approach is strongly recommended.)
• Sentinel lymphadenectomy alone if one of the following criteria is met:
• Pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1b
• Surgeon elects not to remove additional non-sentinel nodes (This approach is strongly discouraged, but will not preclude participation in B-38.)
• Axillary lymphadenectomy without sentinel node isolation procedure.

Sponsors & Collaborators

• NSABP Foundation Inc: lead
• National Cancer Institute (NCI): collaborator

Study Sites (12)

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

Birmingham, Alabama, 35294, United States

Location

Providence Cancer Center

Anchorage, Alaska, 99508, United States

Location

Robert and Carol Weissman Cancer Center at Martin Memorial

Stuart, Florida, 34994, United States

Location

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

South Shore Hospital

South Weymouth, Massachusetts, 02190, United States

Location

Methodist Estabrook Cancer Center

Omaha, Nebraska, 68114, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Altru Cancer Center at Altru Hospital

Grand Forks, North Dakota, 58201, United States

Location

Community Oncology Group at Cleveland Clinic Cancer Center

Independence, Ohio, 44131, United States

Location

Chestnut Hill Healthcare Cancer Center

Philadelphia, Pennsylvania, 19118, United States

Location

Madigan Army Medical Center - Tacoma

Tacoma, Washington, 98431, United States

Location

Related Publications (1)

• Swain SM, Tang G, Geyer CE Jr, Rastogi P, Atkins JN, Donnellan PP, Fehrenbacher L, Azar CA, Robidoux A, Polikoff JA, Brufsky AM, Biggs DD, Levine EA, Zapas JL, Provencher L, Northfelt DW, Paik S, Costantino JP, Mamounas EP, Wolmark N. Definitive results of a phase III adjuvant trial comparing three chemotherapy regimens in women with operable, node-positive breast cancer: the NSABP B-38 trial. J Clin Oncol. 2013 Sep 10;31(26):3197-204. doi: 10.1200/JCO.2012.48.1275. Epub 2013 Aug 12.

  PMID: 23940225 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Docetaxel; Gemcitabine; Paclitaxel; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Director, Department of Regulatory Affairs
• Organization: NSABP Foundation, Inc

regulatory@nsabp.org

412-339-5300

Study Officials

• Norman Wolmark, MD

  NSABP Foundation Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2004
• First Posted: October 8, 2004
• Study Start: October 1, 2004
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2016
• Last Updated: January 11, 2018
• Results First Posted: December 12, 2017

Record last verified: 2017-12

Locations

US (12)