Chemotherapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+541 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: SWOG Cancer Research Network

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating resected breast cancer. PURPOSE: This randomized phase III trial is comparing 2 different regimens of combination chemotherapy to see how well they work in treating patients who have undergone surgery for stage I, stage II, or stage III breast cancer.

Research Team

Halle C Moore, MD

Principal Investigator

The Cleveland Clinic

George Thomas Budd, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for patients who've had surgery for stage I-III breast cancer. Eligible participants must have operable disease with no T4 tumors, high-risk features based on tumor size and nodal status, and known hormone receptor status. HER2/neu-positive tumors are allowed. Those with HIV, prior malignancy within 5 years (except certain skin or in situ cancers), or previous chemotherapy with specific drugs cannot join.

Inclusion Criteria

I have had surgery to remove breast cancer and affected lymph nodes.

My cancer is at an early or mid-stage and can be operated on.

I know my cancer's estrogen and progesterone receptor status.

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Exclusion Criteria

My tumor is not HER2 positive.

I haven't had cancer in the past 5 years, except for certain skin cancers or early-stage cervical or breast cancer.

My tumor is smaller than 1 cm and doesn't meet certain criteria.

See 3 more

Treatment Details

Interventions

Cyclophosphamide (Alkylating agents)
Doxorubicin Hydrochloride (Anti-tumor antibiotic)
Paclitaxel (Taxane)

Trial OverviewThe study compares two post-surgery chemo regimens using doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see which is more effective against resected breast cancer. It's a phase III trial where patients are randomly assigned to one of the two drug combinations.

Participant Groups

6Treatment groups

Experimental Treatment

Active Control

Group I: Arm VIExperimental Treatment5 Interventions

Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim as in arm V. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

Group II: Arm VExperimental Treatment5 Interventions

Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

Group III: Arm IVExperimental Treatment5 Interventions

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III.

Group IV: Arm IIExperimental Treatment5 Interventions

(closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I.

Group V: Arm IActive Control5 Interventions

(closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.

Group VI: Arm IIIActive Control5 Interventions

(closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.

Cyclophosphamide is already approved in Canada, Japan for the following indications: