Docetaxel Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer

NCT00343512 | Terminated Phase 2 Results DMC

• 3 other identifiers: VICC BRE 0368VICC-BRE-0368VICC-11239
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Dose-dense scheduling with (peg)filgrastim support may improve the clinical and pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant docetaxel therapy. PURPOSE: To evaluate whether dose-dense scheduling with (peg)filgrastim support may improve the clinical and pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant docetaxel therapy. To determine the changes in molecular markers that occurs with single agent docetaxel, tissue will be obtained at the end of the four cycles of docetaxel (either by repeat biopsy or definitive surgery).

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number Participants to Achieve Pathologic Complete Response

  whether or not patient has pathologic complete response (pCR) to dose dense docetaxel in the neoadjuvant setting (pCR = no residual viable tumor on histologic analysis)

  3 month

Secondary Outcomes (2)

• Safety Profile Based on Number of Patients With Each Worst-grade Toxicity

  Through 30 days after completion of treatment

• Tumor Response as Measured by Ultrasound

  At screening, 8 weeks and at surgery (within 14-21 days)

Study Arms (1)

Therapeutic Intervention

EXPERIMENTAL

Drug: docetaxel; Genetic: protein expression analysis; Other: laboratory biomarker analysis; Procedure: biopsy; Procedure: conventional surgery; Procedure: neoadjuvant therapy

Interventions

docetaxel DRUG

Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles

Also known as: Taxotere

Therapeutic Intervention

protein expression analysis GENETIC

protein expression analysis

Therapeutic Intervention

laboratory biomarker analysis OTHER

laboratory biomarker analysis

Therapeutic Intervention

biopsy PROCEDURE

biopsy

Therapeutic Intervention

conventional surgery PROCEDURE

conventional surgery

Therapeutic Intervention

neoadjuvant therapy PROCEDURE

neoadjuvant therapy

Therapeutic Intervention

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed invasive carcinoma of the breast by core biopsy
• Tumor ≥ 2 cm in greatest dimension(may be either node positive or node negative disease
• Patients with non-metastatic breast cancer who are in the judgment of the treating medical oncologist considered to be of sufficiently high risk to warrant adjuvant chemotherapy
• Patients with internal mammary, supraclavicular and/or axillary node involvement are eligible. Patients with inflammatory breast cancer are eligible
• Patients with T0 disease but palpable and measurable adenopathy are eligible for this trial. All sites of disease should be noted and followed
• Hormone receptor status:
• Not specified
• PATIENT CHARACTERISTICS:
• ECOG performance status 0-1
• Menopausal status not specified
• Female ≥ 18 years old
• Absolute neutrophil count ≥ 1,000/mm\^3
• Hemoglobin ≥ 8 g/dL
• Platelet count ≥ 100,000/mm\^3
• Creatinine ≤ 1.5 times upper limit of normal (ULN)

You may not qualify if:

• Prior radiotherapy to the ipsilateral breast
• Patients who have had radiation to the contralateral breast are eligible
• Evidence of distant metastatic disease (i.e., lung, liver, bone, brain)
• Pregnant of breastfeeding
• Patients who have congestive heart failure, angina pectoris, uncontrolled cardiac arrhythmia, or other significant heart disease, or who have had a myocardial infarction within the past year
• Patients with \> grade 1 peripheral neuropathy
• Patients with a history of hypersensitivity reaction to products containing polysorbate 80 (Tween 80)
• Patients receiving an investigational anticancer drug within 3 weeks of registration
• Patients with serious medical illness that in the judgment of the treating physician, places the patient at risk.

Sponsors & Collaborators

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

Study Sites (2)

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms

Interventions

Docetaxel; Biopsy; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Combined Modality Therapy; Therapeutics

Limitations and Caveats

All adverse events have been included in the "other adverse event" section. They are not differentiated by causality (eg. related to disease, con-meds).

Results Point of Contact

• Title: Bapsi Chak, M.D.
• Organization: Vanderbilt-Ingram Cancer Center

615-322-2555

Study Officials

• A. Bapsi Chakravarthy, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• 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: June 22, 2006
• First Posted: June 23, 2006
• Study Start: February 1, 2004
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2011
• Last Updated: April 27, 2012
• Results First Posted: November 9, 2010

Record last verified: 2012-04

Locations

US (2)