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

Phase 1
Not Enrolling
Breast Cancer

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Trial Information

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

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.

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

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With Reoccurrence

Outcome Description:

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).

Outcome Time Frame:

Median of 50 months

Safety Issue:


Principal Investigator

Aman U. Buzdar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2002

Completion Date:

August 2011

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Capecitabine
  • Docetaxel
  • Paclitaxel
  • Taxotere
  • Taxol
  • Xeloda
  • Taxanes
  • Operable Breast Cancer
  • Breast Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030