Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 May 20;7(1):55.
doi: 10.1038/s41523-021-00264-2.

NRG Oncology/NSABP B-47 menstrual history study: impact of adjuvant chemotherapy with and without trastuzumab

Patricia A Ganz  1   2 , Reena S Cecchini  3   4 , Louis Fehrenbacher  3   5 , Charles E Geyer Jr  3   6 , Priya Rastogi  3   7 , John P Crown  3   8 , Michael P Thirlwell  3   9 , David M Ellison  3   10 , Jean-Francois Boileau  3   11 , Patrick J Flynn  3   12 , Jong-Hyeon Jeong  3   4 , Eleftherios P Mamounas  3   13 , Norman Wolmark  3   4
Affiliations

NRG Oncology/NSABP B-47 menstrual history study: impact of adjuvant chemotherapy with and without trastuzumab

Patricia A Ganz et al. NPJ Breast Cancer. .

Abstract

The NRG Oncology/NSABP B-47 menstrual history (MH) study examined trastuzumab effects on menstrual status and associated circulating reproductive hormones. MH was evaluated by questions related to hysterectomy, oophorectomy, and reported menstrual changes. Pre/perimenopausal women were assessed at entry, 3, 6, 12, 18, 24, 30, and 36 months. Consenting women had estradiol and FSH measurement at entry, 3, 6, 12, 18, and 24 months. Logistic regression determined predictors of amenorrhea and hormone levels at 12, 24, and 36 months. Between 2/8/2011 and 2/10/2015, 3270 women with node-positive/high-risk node-negative HER2-low breast cancer were enrolled. There were 1,458 women enrolled in the MH study; 1231 consented to baseline blood samples. Trastuzumab did not contribute to a higher amenorrhea rate. Amenorrhea predictors were consistent with earlier studies; however, to our knowledge, this is the largest prospective study to include serial reproductive hormone measurements to 24 months and clinical amenorrhea reports to 36 months. These data can help to counsel patients regarding premature menopause risk.

PubMed Disclaimer

Conflict of interest statement

J.F.B.: Jewish General Hospital/Segal Cancer Centre receives funding for research from Roche – JF Boileau, PI; Consultant for Roche; participated on Advisory Boards for Roche. J.P.C.: Research funding (to institution): Eisai, Puma Biotechnology, Roche, Boehringer Ingelheim; Employment: OncoMark, Ltd.; Honoraria: Eisai, Puma Biotechnology; MSD Oncology, Pfizer, G1 Therapeutics; Novartis; Speaker’s Bureau: Boehringer Ingelheim, Genomic Health, Roche, Pfizer; Shares: OncoMark Ltd; Travel and accommodation expenses: Pfizer, MSD, Abbvie, Astrazeneca, Novartis. P.A.G.: member of the Breast Cancer Research Foundation scientific advisory board. E.P.M.: Consultant: Genentech/Roche, Exact Sciences, Daiichi Sankyo, Biotheranostics, Puma Biotechnology, Merk; Speaker’s Bureau: Genentech/Roche, Exact Sciences. P.R.: Travel and accommodations, Genentech/Roche, AstraZeneca, and Lilly. N.W.: Research Funding to institution: AstraZeneca/MedImmune (Inst), NSABP Foundation (Inst). All remaining authors declare no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT Diagram. NSABP B-47 Menstrual History Sub-study.
Fig. 2
Fig. 2
Distribution of Combined Estradiol and FSH levels over Time.
Fig. 3
Fig. 3
Mean Follicle-stimulating Hormone (FSH) Levels Respectively over Time in NSABP B-47. Levels are presented by: treatment group (a), chemotherapy regimen (b), HR status/endocrine therapy use (c), age group (d), and BMI (e). A higher FSH level indicates a late premenopausal/postmenopausal range. Adjusted least-square means for time points 3 months and beyond were obtained from a mixed model for repeated measures analysis of the FSH level. The model includes age, FSH baseline level, the variable of interest, time, and variable-by-time interaction.
See this image and copyright information in PMC

References

    1. Fehrenbacher L, et al. NSABP B-47/NRG Oncology phase III randomized trial comparing adjuvant chemotherapy with or without trastuzumab in high-risk invasive breast cancer negative for HER2 by FISH and with IHC 1+ or 2. J. Clin. Oncol. 2020;38:444–453. doi: 10.1200/JCO.19.01455. - DOI - PMC - PubMed
    1. Ganz PA, et al. Menstrual history and quality-of-life outcomes in women with node-positive breast cancer treated with adjuvant therapy on the NSABP B-30 trial. J. Clin. Oncol. 2011;29:1110–1116. doi: 10.1200/JCO.2010.29.7689. - DOI - PMC - PubMed
    1. Zhao J, et al. What lies behind chemotherapy-induced amenorrhea for breast cancer patients: a meta-analysis. Breast Cancer Res. Treat. 2014;145:113–128. doi: 10.1007/s10549-014-2914-x. - DOI - PubMed
    1. Lambertini M, et al. Adjuvant anti-HER2 therapy, treatment-related amenorrhea, and survival in premenopausal HER2-positive early breast cancer patients. J. Natl Cancer Inst. 2019;111:86–94. doi: 10.1093/jnci/djy094. - DOI - PMC - PubMed
    1. Abusief ME, Missmer SA, Ginsburg ES, Weeks JC, Partridge AH. The effects of paclitaxel, dose density, and trastuzumab on treatment-related amenorrhea in premenopausal women with breast cancer. Cancer. 2010;116:791–798. doi: 10.1002/cncr.24835. - DOI - PubMed