SWOG clinical trial number
S0230

Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer

Closed
Phase
III
Accrual
56%
Published
Abbreviated Title
CANCER CONTROL - Prevention of Ovarian Failure Following Chemotherapy in Early Stage Breast Cancer
Activated
10/01/2003
Participants
NCORP, Members, Medical Oncologists, Surgeons, ECOG, CALGB, Affiliates, IBCSG

Research committees

Breast Cancer
Cancer Survivorship

Treatment

Goserelin Acetate Surgery

Eligibility Criteria Expand/Collapse

Premenopausal women with a histologically confirmed diagnosis of operable Stage I, II, IIIA invasive breast cancer; patients who have completed surgery must have pathologic Stage I, II, or IIIa disease; patients to be treated in the pre-operative setting may be staged clinically but must have operable disease; both estrogen receptor negative and progesterone receptor negative tumors; bilateral synchronous invasive breast cancer diagnosed within 1 month of each other are eligible if both primary tumors hormone receptor negative; must be age 18 or greater and under age 50; planned treatment must include 3 to 6 months or cycles of an alkylating agent containing postoperative chemotherapy regimen anthracycline-based or non-anthracycline based; must not start planned chemotherapy prior to registration for S0230; must have modified radical mastectomy or local excision of all tumors plus axillary lymph node dissection and/or sentinel node resection prior to registration; all resection margins must be histologically negative for invasive cancer/ductal carcinoma in situ; resection margins positive for lobular carcinoma in situ eligible; must be registered within 84 days after final surgical procedure required to adequately treat primary tumor or axilla; not receive prior cytotoxic chemotherapy; must not have received estrogen, antiestrogens, selective estrogen receptor modulators, aromatase inhibitors, or hormonal forms of contraception within the past month with the following exceptions: (1)women under the age of 35 may have had recent use of oral contraceptive pills but these must be discontinued prior to randomization (2) for women of all ages, up to two months of hormonal treatments for oocyte collection for the purposes of in vitro fertilization and cryopreservation of embryos or oocytes is permitted provided these treatments are complete prior to randomization; women using oral contraceptive pills or hormonal treatments for oocyte collection during the month prior to enrollment must have documentation for FSH and estradiol levels in the premenopausal range; no prior malignancy except adequately treated basal cell/squamous cell skin cancer, in situ, cancer or disease-free for five years; PS=0-2 by Zubrod criteria; no pregnant or nursing women

1.0 Cancer Control Credit

Publication Information Expand/Collapse

2019

Final Analysis of the Prevention of Early Menopause Study (POEMS)/SWOG Intergroup S0230

H Moore;J Unger;K-A Phillips;F Boyle;E Hitre;A Moseley;D Porter;P Francis;L Goldstein;H Gomez;C Vallejos;A Partridge;S Dakhil;A Garcia;J Gralow;J Lombard;J Forbes;S Martino;W Barlow;C Fabian;L Minasian;F Meyskens;R Gelber;G Hortobagyi;K Albain Journal of the National Cancer Institute Feb 1;111(2):210-213; Oct 27. doi: 10.1093/jnci/djy185. [Epub ahead of print]

PMid: PMID30371800

2018

Gonadotropin-releasing hormone analogs during chemotherapy for preservation of ovarian function and fertility in premenopausal early breast cancer patients: a systemic review and meta-analysis of individual patient-level data [Review]

M Lambertini;H Moore;RC Leonard;S Loibl;P Munster;M Bruzzone;L Boni;J Unger;RA Anderson;K Metha;S Minton;F Poggio;K Albain;DJA Adamson;B Gerber;A Cripps;G Bertelli;S Seiler;M Ceppi;A Partridge;L Del Mastro Journal of Clinical Oncology Jul 1;36(19):1981-1990; May 2:JCO2018780858. doi: 10.1200/JCO.2018.78.0858. [Epub ahead of print]

PMid: PMID29718793 | PMC number: PMC Journal - In Process

2017

Final analysis of SWOG S0230/Prevention of Early Menopause Study (POEMS)

HCF Moore;JM Under;KA Phillips;F Boyle;E Hitre;A Moseley;D Porter;PA Francis;LJ Goldstein;HL Gomez;C Vallejos;AH Partridge;S Dakhil;A Garcia;J Gralow;JM Lombard;JF Forbes;S Martino;W Barlow;C Fabian;L Minasian;F Meyskens;RD Gelber;G Hortobagyi;K Albain San Antonio Breast Cancer Symposium (December 5-9, 2017, San Antonio, TX), poster

Pooled analysis of five randomized trials investigating temporary ovarian suppression with gonadotropin-releasing hormone analogs during chemotherapy as a strategy to preserve ovarian function and fertility in premenopausal early breast cancer patients

M Lambertini;H Moore;RCF Leonard;S Loibl;P Munster;M Bruzzone;L Boni;J Unger;RA Anderson;K Mehta;S Minton;S Poggio;K Albain;DJA Adamson;B Gerber;A Cripps;G Bertelli;S Seiler;M Creppi;AH Partridge;L Del Mastro San Antonio Breast Cancer Symposium abst. #GS4-01, oral presenation

2015

Goserelin for Ovarian Protection during Breast-Cancer Adjuvant Chemotherapy

H Moore;J Unger;KA Phillips;F Boyle;E Hitre;D Porter;P Francis;L Goldstein;H Gomez;C Vallejos;A Partridge;S Dhakil;A Garcia;J Gralow;J Lombard;J Forbes;S Martino;W Barlow;C Fabian;L Minasian;F Meyskens;R Gelber;G Hortobagyi;K Albain New England Journal of Medicine, Mar 5; 372(10):923-932

PMid: PMID25738668 | PMC number: PMC4405231

2014

Phase III Trial (Prevention of Early Menopause Study [POEMS]-SWOG S0230) of LHRH Analog during Chemotherapy to Reduce Ovarian Failure in Early Stage, Hormone-Receptor Negative Breast Cancer: An International Intergroup Trial of SWOG, IBCSG, ECOG, CALGB (Alliance)

HCF Moore;JM Unger;K-A Phillips;F Boyle;E Hitre;D Porter;P Francis;L Minasian;R Gelber;LJ Goldstein;HL Gomez Moreno;C Vallejos;AH Partridge;S Dakhil;S Martino;W Barlow;C Fabian;FL Meyskens;GN Hortobagyi;K Albain Journal of Clinical Oncology 32:5s (suppl; abstr LBA505); ASCO Annual Meeting (May 30-June 3, 2014, Chicago, IL), oral;

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