Endocrine Therapy Interruption for Breast Cancer During Pregnancy

(POSITIVE Trial)

Not currently recruiting at 235 trial locations

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: International Breast Cancer Study Group

Must be taking: Endocrine therapy

Disqualifiers: Post-menopausal, Metastatic cancer, Noncompliance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether pausing hormone therapy (endocrine therapy) to allow pregnancy affects the risk of breast cancer recurrence. It focuses on women with hormone receptor-positive breast cancer who wish to become pregnant. Suitable candidates have undergone hormone therapy for 18 to 30 months, have early-stage breast cancer, and want to pause treatment to try for a baby. The trial also examines fertility, pregnancy, and emotional well-being during this process. As an unphased trial, it offers a unique opportunity for women to explore family planning options while contributing to important research on breast cancer and pregnancy.

Will I have to stop taking my current medications?

The trial requires participants to stop their current endocrine therapy within 1 month prior to enrollment. This is to allow for a temporary interruption of the therapy to permit pregnancy.

What prior data suggests that endocrine therapy interruption is safe for women with breast cancer during pregnancy?

Research has shown that taking a break from hormone therapy for women who want to get pregnant does not seem to worsen breast cancer in the short term. One study found no clear increase in breast cancer recurrence when therapy was paused for pregnancy. Additionally, the best evidence suggests that pregnancy after breast cancer does not raise the risk of recurrence.

Overall, this information indicates that pausing hormone therapy to become pregnant is generally safe for women with hormone-sensitive breast cancer. It is always important to discuss any concerns with a healthcare provider to better understand personal circumstances. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the potential of endocrine therapy interruption during pregnancy for breast cancer patients because it offers a unique approach to managing cancer while allowing women to pursue parenthood. Unlike the continuous use of endocrine therapies like tamoxifen or aromatase inhibitors, which are standard treatments to prevent cancer recurrence, this approach temporarily halts the medication, providing a safe window for pregnancy. This method could empower women with hormone receptor-positive breast cancer to balance treatment and family planning, offering more personalized and flexible care options.

What evidence suggests that endocrine therapy interruption is effective for breast cancer during pregnancy?

Research has shown that taking a break from hormone therapy for breast cancer does not raise the risk of the cancer returning in the short term for women who wish to become pregnant. In this trial, participants will interrupt endocrine therapy after completing 18 to 30 months of treatment. One study found that most women who paused their treatment were able to conceive, and over 60% successfully had a baby. Many younger women with breast cancer have safely paused their therapy to have a child. Additionally, 85% of these women restarted their hormone treatment after giving birth. Overall, these findings suggest that temporarily stopping therapy may be a safe option for women who want to have a baby without increasing their cancer risk. ^{1 2 6 7 8}

Who Is on the Research Team?

Olivia Pagani, MD

Principal Investigator

Oncology Institue of Southern Switzerland (IOSI)

Are You a Good Fit for This Trial?

This trial is for premenopausal women aged 18-42 who had breast cancer and wish to become pregnant. They must have completed at least 18 months of endocrine therapy, be without current cancer evidence, and agree to follow-up and data handling. Women with BRCA mutations or prior treatments within a clinical trial are eligible.

Inclusion Criteria

I have been part of a clinical trial for hormone therapy or received preventive drug treatment.

I want to become pregnant.

Patient must be accessible for follow-up

Exclusion Criteria

I do not have any health conditions that would make it unsafe for me to join the study.

I have or had another type of cancer besides breast cancer.

I have had a hysterectomy, both ovaries removed, or radiation to the ovaries.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Endocrine Therapy Interruption

Participants interrupt endocrine therapy after having completed between ≥ 18 months and ≤ 30 months to permit pregnancy

3 months

1 visit (in-person) for therapy interruption

Pregnancy Attempt

Participants attempt conception after a safe period post-endocrine therapy interruption

Up to 24 months

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pregnancy outcomes and breast cancer recurrence

Up to 14 years

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Endocrine therapy interruption

Trial Overview

The study tests the safety of temporarily stopping endocrine therapy in young women who want to get pregnant after breast cancer treatment. It will assess the risk of cancer recurrence and examine fertility, pregnancy outcomes, and psychological well-being related to fertility concerns.

How Is the Trial Designed?

Group I: Endocrine therapy interruption Experimental Treatment 1 Intervention

Endocrine therapy interruption after having completed between ≥ 18 months and ≤ 30 months.

Who Is Running the Clinical Trial?

International Breast Cancer Study Group

Lead Sponsor

Trials

29

Recruited

25,100+

ETOP IBCSG Partners Foundation

Lead Sponsor

Trials

66

Recruited

58,200+

Alliance for Clinical Trials in Oncology

Collaborator

Trials

521

Recruited

224,000+

Canadian Cancer Trials Group

Collaborator

Trials

135

Recruited

70,300+

Breast International Group

Collaborator

Trials

34

Recruited

53,600+

Published Research Related to This Trial

Endocrine therapy is essential for treating premenopausal women with early-stage hormone receptor-positive breast cancer, but there is still uncertainty about the best strategies for using tamoxifen and estrogen deprivation alongside chemotherapy.

Research is ongoing to find better markers for predicting how well patients will respond to endocrine therapy and to understand the unique side effects that young women may experience from this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant hormonal therapy for premenopausal women with breast cancer. Brown, RJ., Davidson, NE.[2015]

A 50-year-old breast cancer patient experienced significant adverse effects from tamoxifen, including hot flushes, hyperhidrosis, urinary frequency, and depression, which negatively impacted her quality of life.

After 25 days of treatment with traditional Korean herbal medicine and acupuncture, the patient's symptoms improved significantly, indicating that these interventions may help alleviate tamoxifen-induced side effects in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional Korean medicine treatment for tamoxifen associated adverse events of breast cancer patient: A CARE - Compliant case report. Seo, J., Lee, D., Jo, HG.[2021]

Citations

1.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2212856

Interrupting Endocrine Therapy to Attempt Pregnancy after ...

These results suggest that although endocrine therapy for a period of 5 to 10 years substantially improves disease outcomes in patients with ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02308085

Study Details | NCT02308085 | Pregnancy Outcome and ...

For women desiring pregnancy after a breast cancer, 5-10 years of endocrine therapy may substantially reduce the chance of conception; however, a shorter ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10731361/

Pregnancy wishes after breast cancer—an unsettled ...

According to the reported results, 85% of the patients indeed were resuming their endocrine treatment, most usually tamoxifen, after the interruption. In this ...

4.

aacr.org

aacr.org/about-the-aacr/newsroom/news-releases/breast-cancer-patients-who-interrupted-endocrine-therapy-to-pursue-pregnancy-did-not-experience-worse-short-term-recurrence-rates/

Breast Cancer Patients Who Interrupted Endocrine ...

Most were able to conceive and more than 60 percent gave birth. SAN ANTONIO – Breast cancer patients who paused their endocrine therapy to ...

5.

dana-farber.org

dana-farber.org/newsroom/news-releases/2023/international-study-shows-many-younger-women-with-breast-cancer-can-safely-have-a-baby

International study shows many younger women with ...

These data from the POSTIVE study show that many of our younger patients can safely pause their endocrine therapy to pursue pregnancy.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37133584/

Interrupting Endocrine Therapy to Attempt Pregnancy after ...

The prespecified safety threshold was the occurrence of 46 breast cancer events during this period. Breast cancer outcomes in this treatment- ...

7.

esmoopen.com

esmoopen.com/article/S2059-7029(23)01272-3/fulltext

Safety of pregnancy after breast cancer in young women ...

Safety of pregnancy after breast cancer in young women with hormone receptor-positive disease: a systematic review and meta-analysis

8.

mayo.edu

mayo.edu/research/clinical-trials/cls-20310178

Pregnancy Outcome and Safety of Interrupting Therapy for ...

The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer.