Clinical trial NCT00002582: Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer
Official title: UKCCCR RANDOMISED TRIAL OF ADJUVANT ENDOCRINE THERAPY AND CHEMOTHERAPY IN WOMEN WITH EARLY BREAST CANCER, THE ADJUVANT BREAST CANCER (ABC) TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: Cancer Research Campaign Clinical Trials Centre
name: Scottish Cancer Therapy Network
name: Yorkshire Regional Clinical Trials Research Unit
First posted: 2003-07-08
Enrollment: 6000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combination chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without chemotherapy and/or ovarian ablation in treating women with stage I, stage II, or stage IIIA breast cancer.

Detailed description: OBJECTIVES:

* Estimate overall and relapse-free survival of women with early-stage breast cancer receiving adjuvant tamoxifen with or without adjuvant chemotherapy and/or ovarian suppression.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution and choice of randomization option.

Postmenopausal women are randomized to the first or second groups.

Randomization for pre- and perimenopausal women is based on the clinician's judgement of appropriate adjuvant therapy (chemotherapy and/or ovarian suppression). Patients may be randomized as follows: among all four groups; for chemotherapy alone (first versus second group); for ovarian suppression alone (first versus third group); for ovarian suppression with nonrandomized assignment to chemotherapy (second versus forth group); for chemotherapy with nonrandomized assignment to ovarian suppression (second versus fourth group).

* First group: Patients receive tamoxifen by mouth every day for 5 years.
* Second group: Patients receive tamoxifen plus cyclophosphamide, methotrexate, fluorouracil (CMF) or doxorubicin/cyclophosphamide (AC). CMF is given every month for 6 courses; AC is given every 3 weeks for 4 courses.
* Third group: Patients receive tamoxifen plus ovarian suppression by oophorectomy, radiation castration, or leuprolide or goserelin.
* Fourth group: Patients receive tamoxifen plus ovarian suppression plus chemotherapy with CMF or AC.

Patients are followed for overall and relapse-free survival.

PROJECTED ACCRUAL: Approximately 6,000 women (4,000 premenopausal, 2,000 postmenopausal) will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed invasive carcinoma of the breast for which adjuvant systemic therapy is appropriate

  * Stage I, II, or IIIA
  * Pathologically positive or negative nodes
  * Any size primary tumor
* No edema, peau d'orange, infiltration of the skin, or direct extension to the chest wall
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* Not specified

Sex:

* Female

Menopausal status:

* Pre-, peri-, or postmenopausal

Performance status:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No prior malignancy except:

  * Basal cell carcinoma
  * Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* See Disease Characteristics

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* See Disease Characteristics

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* No prior systemic treatment for breast cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Cancer Research Campaign Trials Unit-Birmingham (CRCTU)
state: England
city: Glasgow
country: United Kingdom
facility: Beatson Oncology Centre
state: Scotland
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: John R. Yarnold, MD, FRCR
role: STUDY_CHAIR
affiliation: Cancer Research Campaign Clinical Trials Centre
name: Helena Earl, MBBS, PhD, FRCP
role: STUDY_CHAIR
affiliation: University of Glasgow
name: Stanley B. Kaye, MD, FRCP
role: STUDY_CHAIR
affiliation: Leeds Cancer Centre at St. James's University Hospital
name: Tim J. Perren, MD
role: STUDY_CHAIR
References:
citation: Perren TJ. Adjuvant therapy for operable breast cancer; more answers, new questions. Br J Cancer. 1995 Jun;71(6):1142-4. doi: 10.1038/bjc.1995.223. No abstract available.
citation: Brunt AM. The UKCCCR adjuvant breast cancer (ABC) trial. ABC Trial Steering Committee. Clin Oncol (R Coll Radiol). 1994;6(4):209-10. doi: 10.1016/s0936-6555(05)80287-0. No abstract available.
citation: Yarnold JR, Bliss JM, Brunt M, Earl H, Kaye S, Mason M, Mossman J, Perren T, Richards M. Management of breast cancer. Refer women to multidisciplinary breast clinics. BMJ. 1994 Mar 12;308(6930):714-5. doi: 10.1136/bmj.308.6930.714a. No abstract available.
citation: Bliss JM, Yarnold JR. Treatment of early breast cancer. Lancet. 1992 Apr 11;339(8798):936. doi: 10.1016/0140-6736(92)90981-8. No abstract available.
citation: Adjuvant Breast Cancer Trials Collaborative Group. Polychemotherapy for early breast cancer: results from the international adjuvant breast cancer chemotherapy randomized trial. J Natl Cancer Inst. 2007 Apr 4;99(7):506-15. doi: 10.1093/jnci/djk108.
citation: Adjuvant Breast Cancer Trials Collaborative Group. Ovarian ablation or suppression in premenopausal early breast cancer: results from the international adjuvant breast cancer ovarian ablation or suppression randomized trial. J Natl Cancer Inst. 2007 Apr 4;99(7):516-25. doi: 10.1093/jnci/djk109.