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

NCT00647218 | Completed DMC

• 3 other identifiers: VCC BRE 9936P30CA068485VU-VICC-BRE-9936
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 6

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response Rate

  9 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

Experimental

EXPERIMENTAL

Drug: Post-operative adjuvant therapy; Drug: neoadjuvant therapy; Procedure: therapeutic surgical procedure; Radiation: Radiation therapy with concurrent Paclitaxel; Drug: Hormonal Therapy

Interventions

Post-operative adjuvant therapy DRUG

Adriamycin 60 mg/m2 IV over 20 minutes and Cytoxan 600 mg/m2 IV over 1 hour will be given every three weeks for 4 cycles.

Also known as: None noted

Experimental

neoadjuvant therapy DRUG

Paclitaxel 175 mg/m2 IV every 3 weeks x 3 cycles

Also known as: None noted

Experimental

therapeutic surgical procedure PROCEDURE

Modified radical mastectomy or segmental mastectomy plus axillary dissection 6-8 weeks following completion of chemotherapy/Radiotherapy.

Also known as: None noted

Experimental

Radiation therapy with concurrent Paclitaxel RADIATION

Radiation to breast 4680 cGy/26 fractions with concurrent Paclitaxel 30 mg/m2, twice per week

Also known as: None noted

Experimental

Hormonal Therapy DRUG

After completion of postoperative adjuvant Adriamycin and Cytoxan, hormonal therapy should be given at the discretion of the treating physician for all post-menopausal ER and/or PR positive patients. It is also recommended for pre-menopausal patients who are ER and/or PR positive.

Experimental

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically documented invasive carcinoma of the breast\* * Tumor ≥ 2 cm in greatest dimension (e.g., T2-4) and any nodal status (e.g., N0-3), including locally advanced disease, as defined by the following criteria: * Primary tumor ≥ 5 cm * Tumor of any size with direct extension to the chest wall or skin * Inflammatory breast cancer (T4d) * Metastasis to ipsilateral internal mammary node * Ipsilateral lymph nodes that are clinically fixed to each other or to other structures (N2) NOTE: \*Diagnosis may be made by core or tru-cut biopsies * Measurable or evaluable tumor * Measurable disease is defined as any mass that can be reproducibly measured in two perpendicular dimensions * Evaluable disease is defined as any lesion visible by mammogram or palpable by physical exam that does not fit the above criteria of measurability * Planning to undergo breast conservation surgery * Willing to undergo AND is a candidate for radiotherapy, in the judgement of the treating radiation oncologist * No evidence of distant metastatic disease (e.g., lung, liver, bone, brain) * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * ECOG performance status 0-1 * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * Left ventricular ejection fraction ≥ 45% * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancies within the past 5 years, except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix * No history of hypersensitivity reaction to products containing polysorbate 80 (Tween 80) * No serious medical illness that, in the judgment of the treating physician, places the patient at risk * No peripheral neuropathy ≥ grade 2 PRIOR CONCURRENT THERAPY: * Prior tamoxifen as chemoprevention allowed * No prior radiotherapy to the ipsilateral breast * Prior radiotherapy to the contralateral breast is allowed * No prior chemotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

Williamson Medical Center

Frankling, Tennessee, 37067, United States

Location

Jackson-Madison Hospital

Jackson, Tennessee, 38301, United States

Location

Boston Baskin Cancer Center

Memphis, Tennessee, 38104, United States

Location

Methodist Lebonheur Healthcare

Memphis, Tennessee, 38104, United States

Location

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

Vanderbilt-Ingram Cancer Cetner

Nashville, Tennessee, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• A. Bapsi Chakravarthy, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor; Radiation Oncologist

Study Record Dates

• First Submitted: March 28, 2008
• First Posted: March 31, 2008
• Study Start: February 1, 2000
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

US (6)