Paclitaxel and Radiation Therapy in Treating Patients Undergoing Surgery for Stage II or Stage III Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Post-operative adjuvant therapy; Drug: neoadjuvant therapy; Procedure: therapeutic surgical procedure; Radiation: Radiation therapy with concurrent Paclitaxel; Drug: Hormonal Therapy

• Registration Number: NCT00647218
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving paclitaxel and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This clinical trial is studying how well giving paclitaxel together with radiation therapy works in treating patients undergoing surgery for stage II or stage III breast cancer.

Detailed Description

OBJECTIVES:

Primary

* Evaluate the efficacy of paclitaxel and concurrent radiotherapy (as measured by pathologic response rates) in patients with stage II or III breast cancer.

Secondary

* Evaluate the toxicities of this treatment regimen.

* Correlate paclitaxel-induced tumor response with local recurrence-free survival, distant disease-free survival, and overall survival.

* Evaluate protein expression profiles by mass spectrometry in biopsy material and blood specimens collected before and after treatment with paclitaxel.

OUTLINE:

* Neoadjuvant chemotherapy: Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

* Chemoradiotherapy: Beginning 3-4 weeks after completion of neoadjuvant chemotherapy, patients receive paclitaxel IV over 1 hour twice weekly and undergo radiotherapy once daily, 5 days a week, for 6½ weeks.

* Surgery: At 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection (e.g., modified radical mastectomy or lumpectomy and axillary node dissection).

* Adjuvant chemotherapy: Beginning 4-6 weeks after surgery, patients receive doxorubicin hydrochloride IV over 20 minutes and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

* Hormonal therapy: After completion of adjuvant chemotherapy, patients with estrogen receptor- and/or progesterone receptor-positive tumor receive hormonal therapy at the discretion of the treating physician.

Patients undergo blood and tissue sample collection periodically to analyze changes in cell cycle by flow cytometry; antibody assays; kinase assays for cyclin B1/CDC2; genetic assays for p53, p21, and other molecular markers; and protein expression assays by mass spectrometry.

After completion of study therapy, patients are followed periodically.

Study Timeline

• Study Start: 2000-02
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-03-28
• Study First Posted: 2008-03-31
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Post-operative adjuvant therapy	-
Experimental	neoadjuvant therapy	-
Experimental	Radiation therapy with concurrent Paclitaxel	-
Experimental	Hormonal Therapy	-
Experimental	therapeutic surgical procedure	-

Primary Outcome Measures

Name	Time	Method
Pathologic Complete Response Rate	9 weeks

Secondary Outcome Measures

Name	Time	Method
Toxicity paclitaxel and radiation	at 18 weeks
Correlation of tumor response with local recurrence-free survival, distant disease-free survival, and overall survival	at time of disease progression or death by any cause
Protein expression profiles as measured by mass spectrometry before and after treatment with paclitaxel	Baseline and 18 weeks

Trial Locations

Locations (6)

Meharry Medical College; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Cetner; 🇺🇸 Nashville, Tennessee, United States

Methodist Lebonheur Healthcare; 🇺🇸 Memphis, Tennessee, United States

Boston Baskin Cancer Center; 🇺🇸 Memphis, Tennessee, United States

Williamson Medical Center; 🇺🇸 Frankling, Tennessee, United States

Jackson-Madison Hospital; 🇺🇸 Jackson, Tennessee, United States