Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer

Study Description

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Brief Summary:

Primary Objectives:

• Determine the impact of each regimen on the disease free and overall survival of patients with operable breast cancer.
• Determine the ability of docetaxel/capecitabine to downstage primary breast cancer when administered in the neoadjuvant setting when compared with weekly paclitaxel.
• Determine the ability of each regimen to enhance breast conservation therapy when administered in the neoadjuvant setting. (See protocol text for additional objectives and details).

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Paclitaxel; Drug: Docetaxel; Drug: Capecitabine	Phase 1

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	603 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer
Study Start Date :	November 2002
Actual Primary Completion Date :	July 2008
Actual Study Completion Date :	August 2011

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Weekly Paclitaxel (WP); Weekly Paclitaxel (WP) for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles	Drug: Paclitaxel; 80 mg/m^2 by vein (IV) Weekly Over 1 Hour x 12 Weeks; Other Name: Taxol
Experimental: Docetaxel and Capecitabine (DX); Docetaxel + Capecitabine (DX) days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.	Drug: Docetaxel; 75 mg/m^2 by vein (IV) Over 1 Hour Once Every 3 Weeks; Other Name: Taxotere Drug: Capecitabine; 1500 mg/m^2 by mouth Twice Daily x 2 Weeks; Other Name: Xeloda

Outcome Measures

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Primary Outcome Measures :

1. Percentage of Participants With Reoccurrence [ Time Frame: Median of 50 months ]
   Percentage of participants where number with local recurrence, distant metastasis, or death of any cause at 50 months is divided by total number of participants and used as primary efficacy end point to compare paclitaxel to combination docetaxel and capecitabine in breast cancer treatment for preventing recurrence (return of cancer).

Secondary Outcome Measures :

1. Proportion of Participants With Pathological Complete Response [ Time Frame: 7 Years ]
   Safety of 2 Different Treatments determined by proportion of participants who achieved pathological complete response (pCR) between two different treatments; where pCR was defined as no histopathologic evidence of any residual invasive cancer cells in the breast and axillary lymph nodes.
2. Treatment Effectiveness at Eradicating Tumor in the Breast and Lymph Nodes [ Time Frame: 7 years ]
   Effectiveness defined as proportion of patients who were able to have breast conserving surgery (BCS) after preoperative therapy compared to total number of participants.

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Patients with histologic confirmation of invasive, but non-inflammatory carcinoma of the breast.
2. Stage I (T1N0) are not eligible for the neo-adjuvant portion of the protocol.
3. High-risk patients (patients with any of the following: high proliferation rate - Ki67 >35% or poorly differentiated tumors (black's modified grade 3); ER/PR negative; lymphovascular invasion) with stage I disease are eligible for adjuvant therapy.
4. Patients with pure mucinous carcinomas, tubular carcinomas or pure medullary carcinomas are eligible if the patient's tumor is larger than 3 cm in size or if the patient has tumor involvement of the lymph nodes (>2mm).
5. Patients with bilateral breast cancers are eligible.
6. Patients with pN2a (metastasis in four to nine axillary lymph nodes) are eligible as are patients with pN3a (ten or more axillary lymph nodes). Patients with infraclavicular lymph node involvement are NOT eligible.
7. Patients must have clinically measurable disease to be treated in the neoadjuvant setting. This includes patients with a non-palpable primary who have histologically proven lymph node (LN) involvement that is clinically palpable and measurable by ultrasound
8. Histologic confirmation of invasive tumor will be done by core needle biopsy for patients with intact primary tumors. If patients have undergone adequate core biopsy prior to evaluation at MDACC, repeat core biopsy is optional.
9. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.
10. Patients with a prior history of breast cancer are eligible if the current primary breast cancer is of a higher stage than the original breast cancer and the patient has not received any of the current study medications including past doxorubicin.
11. Patients should have adequate bone marrow function, as defined by peripheral granulocyte count of > 1,500/mm3, and platelet count > 100,000/mm3. Patients must have adequate liver function with a bilirubin within normal laboratory values. Transaminases (SGPT) may be up to 2.5x upper limit of normal (ULN) if alkaline phosphatase is < ULN or alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN.
12. In addition, patients should have adequate renal function, defined as a serum creatinine < 2.5 mg% and/or creatinine clearance greater than 51 ml/min as calculated by Cockcroft and Gault Equation: Cockcroft and Gault Equation: Creatinine clearance for males = {(140 - age [yrs])(body weight [kg])}/{(72) (serum creatinine [mg/dL])}. Creatinine clearance for females = 0.85 x male value
13. Patients who had surgical therapy prior to referral will be eligible for randomization to systemic chemotherapy administered in the adjuvant setting.
14. Patients who have overexpression of the her-2/neu oncogene are eligible for the study.

Exclusion Criteria:

1. Patients with N2 (clinical staging) or N3 (clinical staging) nodal disease, inflammatory breast cancer, or metastatic disease are not eligible. This includes patients with infraclavicular and/or supraclavicular lymph node involvement. Patients with pN2a (metastasis in four to nine axillary lymph nodes) are eligible.
2. Patients with pN2b (metastasis in clinically apparent internal mammary lymph nodes in the absence of axillary lymph node metastasis) are not eligible. Patients with T4 lesions in the neoadjuvant setting are not eligible. Patients with limited T4 lesions in the adjuvant setting (for example, focal extension into the skin with negative margins) are eligible.
3. Severe hypersensitivity reactions to agents formulated in either cremophor or polysorbate 80 must be excluded. Patients with hypersensitivity reactions to any of the study medications must be excluded.
4. Those patients with history of other malignancies will be excluded, except non-melanoma skin cancer and non-invasive cervical cancer.
5. Patients with uncompensated congestive heart failure are not eligible. Patients with myocardial infarction within the past 12 months are ineligible.
6. Patients who are pregnant or lactating are not eligible. Women of childbearing potential must have a negative pregnancy test prior to initiation of chemotherapy. Women of childbearing potential who will not use a reliable and appropriate contraceptive method during the study are not eligible.
7. Patients who have had an organ allograft are ineligible.
8. Patients with serious concurrent infections are ineligible.
9. Sexually active male patients unwilling to practice contraception during the study are ineligible.
10. Patients with pre-existing peripheral neuropathy > grade 1.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Roche Pharma AG

Investigators

Principal Investigator:	Aman U. Buzdar, MD	M.D. Anderson Cancer Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

MD Anderson Cancer Center 

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00050167 History of Changes
Other Study ID Numbers:	ID01-580
First Posted:	November 27, 2002
Results First Posted:	August 5, 2011
Last Update Posted:	August 29, 2011
Last Verified:	August 2011

Keywords provided by M.D. Anderson Cancer Center:

Breast Cancer; Capecitabine; Docetaxel; Paclitaxel; Taxotere	Taxol; Xeloda; Taxanes; Operable Breast Cancer

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Paclitaxel; Docetaxel; Taxane; Albumin-Bound Paclitaxel	Capecitabine; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites