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Interrupting Endocrine Therapy to Attempt Pregnancy after Breast Cancer.


ABSTRACT:

Background

Prospective data on the risk of recurrence among women with hormone receptor-positive early breast cancer who temporarily discontinue endocrine therapy to attempt pregnancy are lacking.

Methods

We conducted a single-group trial in which we evaluated the temporary interruption of adjuvant endocrine therapy to attempt pregnancy in young women with previous breast cancer. Eligible women were 42 years of age or younger; had had stage I, II, or III disease; had received adjuvant endocrine therapy for 18 to 30 months; and desired pregnancy. The primary end point was the number of breast cancer events (defined as local, regional, or distant recurrence of invasive breast cancer or new contralateral invasive breast cancer) during follow-up. The primary analysis was planned to be performed after 1600 patient-years of follow-up. The prespecified safety threshold was the occurrence of 46 breast cancer events during this period. Breast cancer outcomes in this treatment-interruption group were compared with those in an external control cohort consisting of women who would have met the entry criteria for the current trial.

Results

Among 516 women, the median age was 37 years, the median time from breast cancer diagnosis to enrollment was 29 months, and 93.4% had stage I or II disease. Among 497 women who were followed for pregnancy status, 368 (74.0%) had at least one pregnancy and 317 (63.8%) had at least one live birth. In total, 365 babies were born. At 1638 patient-years of follow-up (median follow-up, 41 months), 44 patients had a breast cancer event, a result that did not exceed the safety threshold. The 3-year incidence of breast cancer events was 8.9% (95% confidence interval [CI], 6.3 to 11.6) in the treatment-interruption group and 9.2% (95% CI, 7.6 to 10.8) in the control cohort.

Conclusions

Among select women with previous hormone receptor-positive early breast cancer, temporary interruption of endocrine therapy to attempt pregnancy did not confer a greater short-term risk of breast cancer events, including distant recurrence, than that in the external control cohort. Further follow-up is critical to inform longer-term safety. (Funded by ETOP IBCSG Partners Foundation and others; POSITIVE ClinicalTrials.gov number, NCT02308085.).

SUBMITTER: Partridge AH 

PROVIDER: S-EPMC10358451 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Interrupting Endocrine Therapy to Attempt Pregnancy after Breast Cancer.

Partridge Ann H AH   Niman Samuel M SM   Ruggeri Monica M   Peccatori Fedro A FA   Azim Hatem A HA   Colleoni Marco M   Saura Cristina C   Shimizu Chikako C   Sætersdal Anna B AB   Kroep Judith R JR   Mailliez Audrey A   Warner Ellen E   Borges Virginia F VF   Amant Frédéric F   Gombos Andrea A   Kataoka Akemi A   Rousset-Jablonski Christine C   Borstnar Simona S   Takei Junko J   Lee Jeong E JE   Walshe Janice M JM   Ruíz-Borrego Manuel M   Moore Halle C F HCF   Saunders Christobel C   Bjelic-Radisic Vesna V   Susnjar Snezana S   Cardoso Fatima F   Smith Karen L KL   Ferreiro Teresa T   Ribi Karin K   Ruddy Kathryn K   Kammler Roswitha R   El-Abed Sarra S   Viale Giuseppe G   Piccart Martine M   Korde Larissa A LA   Goldhirsch Aron A   Gelber Richard D RD   Pagani Olivia O  

The New England journal of medicine 20230501 18


<h4>Background</h4>Prospective data on the risk of recurrence among women with hormone receptor-positive early breast cancer who temporarily discontinue endocrine therapy to attempt pregnancy are lacking.<h4>Methods</h4>We conducted a single-group trial in which we evaluated the temporary interruption of adjuvant endocrine therapy to attempt pregnancy in young women with previous breast cancer. Eligible women were 42 years of age or younger; had had stage I, II, or III disease; had received adju  ...[more]

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