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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00050167
Recruitment Status : Completed
First Posted : November 27, 2002
Results First Posted : August 5, 2011
Last Update Posted : August 29, 2011
Roche Pharma AG
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE November 25, 2002
First Posted Date  ICMJE November 27, 2002
Results First Submitted Date  ICMJE July 7, 2011
Results First Posted Date  ICMJE August 5, 2011
Last Update Posted Date August 29, 2011
Study Start Date  ICMJE November 2002
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2011)
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).
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2011)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer
Official Title  ICMJE Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer
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).
Detailed Description

Before the study, participants will have a complete physical exam, including blood tests and a chest x-ray. A mammogram and a sonogram of the breast and armpit will be done to record tumor size (for patients who have not had surgery). Sonography of the liver or a CT scan of the abdomen will also be done. In some patients who have not had surgery, 3-4 samples of the breast tumor will be taken to help confirm the diagnosis of breast cancer. A biopsy needle will be used to collect the samples.

During the study, participants will have blood tests done before each dose of chemotherapy. For participants who have not had surgery, a mammogram and sonogram will be done of the breast and armpit after completion of paclitaxel or docetaxel/capecitabine and after completion of fluorouracil, cyclophosphamide, and epirubicin (FEC). These studies will help doctors to keep track of the tumor size and help with the final decision whether to remove all or part of the breast and nearby lymph nodes after completion of chemotherapy.

Participants in this study will be randomly assigned (as in the toss of a coin) to one of two treatment groups. There is an equal chance of being in either group.

Participants in Group I will receive paclitaxel once a week. The drug will be given through a plastic tube in a vein over 1 hour for a total of 12 treatments. Before each treatment, patients will receive the drug Decadron (dexamethasone) through the vein and may receive Zofran (ondansetron), Benadryl (diphenhydramine hydrochloride) and/or cimetidine to help decrease the risk of side effects from paclitaxel.

Participants in Group II will receive docetaxel and capecitabine. Docetaxel will be given once every 3 weeks. Docetaxel will be given through a plastic tube in the vein over 1 hour. Capecitabine will be started the same day docetaxel is given. This medicine is given in a pill form. The doctor will prescribe a dose of these pills based upon body weight and height. Participants will take several pills two times a day for 14 days. Participants will then not take any capecitabine pills for one week, until the next dose of docetaxel is given. This combination of docetaxel and capecitabine will be given four times (over a period of 12 weeks). Before each treatment, patients will receive the drug Decadron (dexamethasone) by mouth.

After treatment with either paclitaxel or docetaxel/capecitabine, all participants will receive the drugs FEC through a plastic tube into a vein. All of these drugs will be given once every three weeks for a total of 4 treatments (12 weeks total). Decadron (dexamethasone), Zofran (ondansetron) and Benadryl (diphenhydramine hydrochloride) will be given before the chemotherapy to help decrease the risk of side effects.

Participants who have a Her-2/neu positive cancer will potentially be eligible to receive trastuzumab therapy for 1 year. This medicine is given through a vein either once a week (over 30 minutes) or once every 3 weeks (over 30 minutes). Your doctor will discuss whether this medicine is appropriate for you.

After all treatment is done, participants whose tumors are sensitive to hormones (estrogen) will take a pill to help decrease the amount of hormone (estrogen) that can reach any tumor cells. This pill will be taken once a day for 5 years.

Participants who have not completed surgery for their cancer before receiving the chemotherapy described above will have surgery to remove all or part of the breast that has cancer. If there are signs that the lymph nodes in the armpit (axilla) contain cancer, these lymph nodes will also be removed.

After chemotherapy and surgery, or after completion of chemotherapy (patients who had surgery done first), participants may then receive radiation treatment to the breast area and armpit once a day (Monday through Friday) for 5-6 weeks.

After the study, participants will return for checkups every 3-4 months during Years 1 and 2, every 6 months during years 3 and 4 and yearly after that. During the check-ups participants will talk with and be examined by their physician. Once a year, patients will have yearly mammograms (as needed), chest-x rays, and blood tests.

This is an investigational study. All of the drugs in this study are approved by the FDA for treatment of breast cancer. A total of 930 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Paclitaxel
    80 mg/m^2 by vein (IV) Weekly Over 1 Hour x 12 Weeks
    Other Name: Taxol
  • 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
Study Arms  ICMJE
  • Experimental: Weekly Paclitaxel (WP)
    Weekly Paclitaxel (WP) for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
    Intervention: Drug: Paclitaxel
  • 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
    • Drug: Capecitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2011)
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00050167
Other Study ID Numbers  ICMJE ID01-580
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Roche Pharma AG
Investigators  ICMJE
Principal Investigator: Aman U. Buzdar, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP