Breast Cancer Clinical Trial
— 12-93Official title:
Adjuvant Therapy for Post/Perimenopausal Patients With Node Positive Breast Cancer Who Are Suitable for Endocrine Therapy Alone.
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy may
fight breast cancer by blocking the uptake of estrogen. Drugs used in chemotherapy use
different ways to stop tumor cells from dividing so they stop growing or die. Combining
chemotherapy with hormone therapy may kill more tumor cells. It is not yet known which
treatment regimen is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy during
or after combination chemotherapy or hormone therapy alone in treating perimenopausal or
postmenopausal women who have stage II or stage IIIA breast cancer.
Status | Completed |
Enrollment | 452 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A to 70 Years |
Eligibility |
DISEASE CHARACTERISTICS: Histologically proven stage T1-3, pN1, M0 carcinoma of the breast
considered suitable for adjuvant treatment with endocrine therapy alone Estrogen receptor
at least 10 fmol/mg cytosol protein or positive on immunohistochemical assay Potentially
curative resection within 6 weeks of entry by one of the following: Total mastectomy with
negative margins Breast-conserving procedure (lumpectomy or quadrantectomy) for tumors
less than 5 cm Adequate re-resection or mastectomy within 4 weeks of initial surgery
required if margins are positive after initial surgery Axillary clearance (not sampling)
required at surgery, with at least 1 node positive upon histopathologic examination of at
least 8 nodes Suspicious manifestations of metastatic disease (e.g., hot spots on bone
scan, skeletal pain of unknown cause) must be proven benign No bilateral breast cancer Any
mass in contralateral breast must be proven benign by biopsy PATIENT CHARACTERISTICS: Age: 70 and under Sex: Women only Menopausal status: Peri/postmenopausal, i.e.: More than 6 months since last normal menstrual period (LNMP) with no prior hysterectomy and no hormone replacement therapy (HRT) Prior hysterectomy and no HRT and either age greater than 55 or age 55 or less with postmenopausal LH, FSH, and E2 levels On HRT and either age 50 or greater or LNMP more than 6 months prior to starting HRT Performance status: Not specified Hematopoietic: WBC greater than 4,000 Platelets greater than 100,000 Hepatic: Bilirubin less than 1.1 mg/dL (20 micromoles/L) AST less than 60 IU/L Renal: Creatinine less than 1.3 mg/dL (120 micromoles/L) Other: No nonmalignant systemic disease that would preclude protocol therapy or prolonged follow-up No psychiatric or addictive disorder that would preclude informed consent No prior or concurrent second malignancy except: Nonmelanomatous skin cancer Adequately treated in situ carcinoma of the cervix Geographically accessible for follow-up PRIOR CONCURRENT THERAPY: No prior therapy for breast cancer other than potentially curative surgery (see Disease Characteristics) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Anti-Cancer Council of Victoria, Melbourne | Carlton South | Victoria |
Australia | Newcastle Mater Misericordiae Hospital | Newcastle | New South Wales |
Australia | Sir Charles Gairdner Hospital, Perth | Perth | Western Australia |
Australia | Royal Prince Alfred Hospital, Sydney | Sydney | New South Wales |
Italy | Centro di Riferimento Oncologico - Aviano | Aviano | |
Italy | Universita di Brescia | Brescia | |
Italy | Istituto Europeo Di Oncologia | Milano | |
Italy | Ospedale Civile Rimini | Rimini | |
Italy | Ospedale San Eugenio | Rome | |
New Zealand | Auckland Adventist Hospital | Auckland | |
Slovenia | Institute of Oncology, Ljubljana | Ljubljana | |
South Africa | Groote Schuur Hospital, Cape Town | Cape Town | |
Sweden | Sahlgrenska University Hospital | Gothenburg (Goteborg) | |
Switzerland | University Hospital | Basel | |
Switzerland | Inselspital, Bern | Bern | |
Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne | |
Switzerland | Hopital des Cadolles, Neuchatel | Neuchatel | |
Switzerland | Kantonsspital - Saint Gallen | Saint Gallen | |
Switzerland | Universitaetsspital | Zurich |
Lead Sponsor | Collaborator |
---|---|
International Breast Cancer Study Group |
Australia, Italy, New Zealand, Slovenia, South Africa, Sweden, Switzerland,
Gianni L, Gelber S, Ravaioli A, Price KN, Panzini I, Fantini M, Castiglione-Gertsch M, Pagani O, Simoncini E, Gelber RD, Coates AS, Goldhirsch A. Second non-breast primary cancer following adjuvant therapy for early breast cancer: a report from the International Breast Cancer Study Group. Eur J Cancer. 2009 Mar;45(4):561-71. doi: 10.1016/j.ejca.2008.10.011. Epub 2008 Dec 4. — View Citation
Gianni L, Panzini I, Li S, Gelber RD, Collins J, Holmberg SB, Crivellari D, Castiglione-Gertsch M, Goldhirsch A, Coates AS, Ravaioli A; International Breast Cancer Study Group (IBCSG). Ocular toxicity during adjuvant chemoendocrine therapy for early breast cancer: results from International Breast Cancer Study Group trials. Cancer. 2006 Feb 1;106(3):505-13. — View Citation
International Breast Cancer Study Group, Pagani O, Gelber S, Price K, Zahrieh D, Gelber R, Simoncini E, Castiglione-Gertsch M, Coates AS, Goldhirsch A. Toremifene and tamoxifen are equally effective for early-stage breast cancer: first results of International Breast Cancer Study Group Trials 12-93 and 14-93. Ann Oncol. 2004 Dec;15(12):1749-59. — View Citation
Kenne Sarenmalm E, Odén A, Ohlén J, Gaston-Johansson F, Holmberg SB. Changes in health-related quality of life may predict recurrent breast cancer. Eur J Oncol Nurs. 2009 Dec;13(5):323-9. doi: 10.1016/j.ejon.2009.05.002. Epub 2009 Jul 12. — View Citation
Keshaviah A, Dellapasqua S, Rotmensz N, Lindtner J, Crivellari D, Collins J, Colleoni M, Thürlimann B, Mendiola C, Aebi S, Price KN, Pagani O, Simoncini E, Castiglione Gertsch M, Gelber RD, Coates AS, Goldhirsch A. CA15-3 and alkaline phosphatase as predictors for breast cancer recurrence: a combined analysis of seven International Breast Cancer Study Group trials. Ann Oncol. 2007 Apr;18(4):701-8. Epub 2007 Jan 20. — View Citation
Pagani O, Gelber S, Simoncini E, Castiglione-Gertsch M, Price KN, Gelber RD, Holmberg SB, Crivellari D, Collins J, Lindtner J, Thürlimann B, Fey MF, Murray E, Forbes JF, Coates AS, Goldhirsch A; International Breast Cancer Study Group. Is adjuvant chemotherapy of benefit for postmenopausal women who receive endocrine treatment for highly endocrine-responsive, node-positive breast cancer? International Breast Cancer Study Group Trials VII and 12-93. Breast Cancer Res Treat. 2009 Aug;116(3):491-500. doi: 10.1007/s10549-008-0225-9. Epub 2008 Oct 25. — View Citation
Pestalozzi BC, Zahrieh D, Mallon E, Gusterson BA, Price KN, Gelber RD, Holmberg SB, Lindtner J, Snyder R, Thürlimann B, Murray E, Viale G, Castiglione-Gertsch M, Coates AS, Goldhirsch A; International Breast Cancer Study Group. Distinct clinical and prognostic features of infiltrating lobular carcinoma of the breast: combined results of 15 International Breast Cancer Study Group clinical trials. J Clin Oncol. 2008 Jun 20;26(18):3006-14. doi: 10.1200/JCO.2007.14.9336. Epub 2008 May 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | Time from randomization to death. | 17 years after randomization | No |
Secondary | Disease-free and systemic disease-free survival. | Time from randomization to recurrence, metastasis, appearance of a second primary tumor or death. | 17 years from randomization | No |
Secondary | Quality of life | Quality of life will be assessed using QL Questionnaires of IBCSG. | 17 years from randomization | No |
Secondary | Toxicity | Assessment of toxicity according to standard criteria. | 17 years after randomization | Yes |
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