Active not recruitingNAINTERVENTIONAL

Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer

This study is for young women who have had early breast cancer and are receiving hormone-blocking therapy. We want to find out if it's safe to briefly stop this treatment to have a baby without increasing the risk of the cancer coming back. Many women are delaying starting a family, and breast cancer can happen before they've had children. While current evidence suggests pregnancy after breast cancer doesn't raise recurrence risk, the impact of interrupting hormone therapy for this isn't fully known. The study will also explore fertility, pregnancy outcomes, and look at the emotional impact of making these choices.

At a glance

Status

Active not recruiting

Phase

Sponsor

ETOP IBCSG Partners Foundation

Enrolment target

518

Start

04 Dec 2014

Estimated completion

01 Dec 2028

Early Breast Cancer

What is this study about?

If you're a young woman who has had early breast cancer and is taking hormone therapy, you might be wondering about having children. We know that many women are waiting longer to start their families, and sometimes breast cancer can happen before they've had a chance to have children. Hormone therapy, which helps reduce the risk of breast cancer coming back, can make it difficult or impossible to get pregnant. This study is designed to explore if it's safe to temporarily stop this therapy so you can try to get pregnant and have a baby.

While previous research has generally shown that getting pregnant after breast cancer doesn't increase the risk of the cancer returning, especially for hormone-sensitive types, we don't have enough information specifically about what happens when hormone therapy is paused. This study aims to fill that gap. It will carefully monitor women who decide to take a break from their hormone treatment to try for a baby, looking closely at whether the cancer is more likely to come back. We also want to learn more about fertility, pregnancy results, and the overall well-being of young women going through this experience.

Taking part in this study could help us understand the best way to support young women after breast cancer who wish to have children. The information gathered will be essential for doctors to give better advice and care in the future. There's also a separate part of the study that will look at your feelings, any worries about fertility, and how you make decisions during this time, which is really important for understanding the emotional side of things.

Key takeaways

This study explores safe pregnancy after early breast cancer.
It focuses on temporarily pausing hormone therapy to allow for conception.
Participation contributes to understanding fertility and peace of mind for young women.
There's a separate part looking at emotional well-being and decision-making.
Eligibility includes specific age, cancer type, and treatment history.
The study monitors both cancer recurrence risk and pregnancy outcomes.

Who may be eligible?

This study is looking for women aged 18 to 42 years old who have been diagnosed with early breast cancer. You should have been receiving hormone therapy for at least 18 months but no more than 30 months, and this therapy must have stopped within the last month before joining the study.

Your breast cancer must have been an early-stage cancer (Stage I-III) that was sensitive to hormones (meaning it was estrogen and/or progesterone receptor positive) and treated with the aim of curing it. You must also have been pre-menopausal when you were diagnosed with breast cancer. It's important that there's no sign of the cancer having returned or spread to other parts of your body. Most importantly, you must wish to become pregnant.

Even if you've had chemotherapy, other cancer treatments, or have certain genetic mutations like BRCA1/2, you might still be able to join. If you've had fertility treatments or frozen eggs/embryos in the past, you could also be eligible. The main goal is to find out if it's safe for women like you to pause their hormone therapy to try for a baby.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 42 years old?
Did you have early-stage, hormone-sensitive breast cancer?
Have you been on hormone therapy for 18-30 months, and stopped it recently?
Do you want to become pregnant?
Is there no sign of your cancer having returned or spread?
Were you pre-menopausal when diagnosed with breast cancer?

Answer every question to see your result.

What does participation involve?

We expect that you will have already been on your hormone therapy for 18 to 30 months, and will have stopped it up to one month before joining the study. We will follow you closely throughout your pregnancy journey and afterwards to see how you are doing, including if your cancer returns. You'll have regular check-ups and assessments. The exact number of visits and tests will be explained in detail by the study team, but generally, this will involve monitoring your health, fertility, and the well-being of both you and your baby. The total duration of your participation will depend on when you get pregnant and how long you need to be followed after birth.

Potential risks and benefits

A potential benefit of joining this study is getting a clearer picture of the safety of pausing your hormone therapy to have a baby, helping you achieve your family goals. The main potential risk is that pausing your treatment might increase the chance of your breast cancer coming back, though current information suggests pregnancy itself doesn't increase this risk. There could also be risks related to pregnancy and birth, though these are not expected to be different from the general population. You are free to withdraw from the study at any time without affecting your medical care.

Locations (211)

Cedars Sinai Medical Centre
Verified postcode
Los Angeles, United States
Stanford Cancer Institute
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Palo Alto, United States
Sharp Memorial Hospital
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San Diego, United States
University of Colorado Cancer Centre - Anschutz Cancer Pavilion
Verified postcode
Aurora, United States
Rocky Mountain Cancer Center
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Boulder, United States
SCL Health Saint Joseph Hospital
Verified postcode
Denver, United States
Poudre Valley Hospital
Verified postcode
Fort Collins, United States
Smilow Cancer Hospital-Derby Care Center
Verified postcode
Derby, United States
Smilow Cancer Hospital Care Center-Fairfield
Verified postcode
Fairfield, United States
Smilow Cancer Hospital Care Center at Saint Francis
Verified postcode
Hartford, United States
Yale University - Yale Cancer Centre
Verified postcode
New Haven, United States
Yale-New Haven Hospital North Haven Medical Center
Verified postcode
North Haven, United States

Common questions

What kind of breast cancer do I need to have had?

You need to have had early-stage breast cancer (Stage I-III) that was sensitive to hormones (estrogen and/or progesterone receptor positive) and was treated with the aim of being cured.

How old do I need to be?

You need to be between 18 and 42 years old when you join the study.

How long should I have been on hormone therapy?

You should have received hormone therapy for at least 18 months but no more than 30 months, and stopped it within one month before joining.

Will I still get my regular medical care outside the study?

Yes, joining the study will not prevent you from receiving your usual medical care from your doctors.

What if I decide I don't want to continue with the study?

You are free to leave the study at any time, for any reason, without it affecting your medical treatment.