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A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients With Axillary Node-Positive Breast Cancer

Phase 3
18 Years
Not Enrolling
Breast Cancer

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Trial Information

A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients With Axillary Node-Positive Breast Cancer


- Compare the disease-free survival and overall survival in patients with node-positive
or high-risk node-negative operable stage II or IIIA breast cancer treated with
docetaxel or paclitaxel after doxorubicin and cyclophosphamide.

- Determine whether the weekly administration of paclitaxel or docetaxel for 12 weeks
improves disease-free survival and overall survival when compared with the conventional
schedule of every 3 weeks for 4 courses after doxorubicin and cyclophosphamide in this
patient population.

- Compare the toxic effects of docetaxel and paclitaxel when administered weekly for 12
weeks versus every 3 weeks for 4 courses in these patients.

- Compare the toxicity of paclitaxel administered every 3 weeks for 4 courses or weekly
for 12 weeks to that of docetaxel administered on the same schedules in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
estrogen receptor status (positive vs negative vs unknown), nodal status (0 positive nodes
vs 1-3 positive nodes vs 4-9 positive nodes vs at least 10 positive nodes), tumor size (no
more than 5 cm vs more than 5 cm vs unknown), and type of prior surgery (mastectomy vs
breast conservation surgery). Patients are randomized to one of four treatment arms.

- Arm I: Patients receive doxorubicin IV and cyclophosphamide IV every 3 weeks for 4
courses (weeks 1-12). Beginning at week 13, patients receive paclitaxel IV over 3 hours
every 3 weeks for 4 courses.

- Arm II: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at
week 13, patients receive paclitaxel IV over 1 hour weekly for 12 weeks.

- Arm III: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at
week 13, patients receive docetaxel IV over 1 hour every 3 weeks for 4 courses.

- Arm IV: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at
week 13, patients receive docetaxel IV over 1 hour weekly for 12 weeks.

Within 4 weeks after completion of chemotherapy, patients with estrogen and/or progesterone
receptor positive tumors receive oral tamoxifen daily for 5 years.

After completion of all chemotherapy, patients with prior segmental mastectomy receive
radiotherapy once daily 5 days per week for 5-6 weeks. Patients with prior modified radical
mastectomy may receive radiotherapy after chemotherapy completion at the investigator's

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study within 1.27

Inclusion Criteria


- Histologically confirmed operable stage IIA, IIB, or IIIA adenocarcinoma of the
breast with histologically involved lymph nodes (T1, 2, or 3; N1 or 2; M0) OR
high-risk node-negative disease (T2 or 3; N0)

- Primary tumor at least 2.1 cm in diameter for node-negative disease

- Bilateral breast disease allowed if at least 1 primary tumor meets the criteria

- Must have had at least 6 axillary lymph nodes removed at dissection and at least one
node positive for metastasis OR

- Sentinel node biopsy negative for metastasis (sentinel node biopsy positive allowed
if enrolled on American College of Surgery Trial Z0011 and have beenrandomized to
receive no axillary dissection)

- Additional axillary nodes may be obtained provided they are also negative for

- Complete tumor removal by either a modified radical mastectomy or local excision plus
axillary lymph node dissection (i.e., breast conservation therapy) or sentinel node

- Tumor-free margins at least 1 mm for both invasive and noninvasive carcinoma
except for lobular carcinoma in situ (less than 1 mm allowed)

- Concurrent enrollment on American College of Surgery Trial Z0010, Z0011, or NSABP
B-32 allowed

- Hormone receptor status:

- Estrogen receptor status positive, negative, or unknown



- 18 and over


- Female

Menopausal status:

- Not specified

Performance status:

- Not specified

Life expectancy:

- Not specified


- Neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 2 times upper limit of normal


- Creatinine no greater than 1.5 mg/dL


- No history of myocardial infarction

- No congestive heart failure

- No significant ischemic or valvular heart disease


- No other prior invasive malignancies within the past 5 years except curatively
treated basal or squamous cell skin cancer or carcinoma in situ of the cervix

- No hypersensitivity to paclitaxel or docetaxel or other similarly formulated drugs
(with Cremophor or polysorbate)

- Not pregnant or nursing

- Fertile patients must use effective barrier contraception


Biologic therapy:

- Not specified


- No prior chemotherapy for breast cancer

Endocrine therapy:

- Prior tamoxifen of no more than 4 weeks duration for breast cancer allowed

- Prior tamoxifen or other selective estrogen receptor modulator (SERM) for
chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications
(e.g., osteoporosis) allowed

- No concurrent tamoxifen or other SERMs


- No prior radiotherapy for this malignancy

- At least 2 weeks since prior radiotherapy to the breast for ductal carcinoma in situ


- See Disease Characteristics

- Less than 84 days since prior surgical procedure to adequately treat primary tumor

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Joseph A. Sparano, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University


United States: Food and Drug Administration

Study ID:




Start Date:

October 1999

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms



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