What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as chemotherapy, endocrine therapy, and targeted therapies, have various side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased risk of infections. Endocrine therapies like tamoxifen may lead to hot flashes, vaginal dryness, and an increased risk of blood clots, while aromatase inhibitors can cause bone density loss and cardiovascular issues. Targeted therapies, such as trastuzumab and lapatinib, are associated with gastrointestinal issues like diarrhea, as well as potential heart problems. These side effects should be discussed with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that may be relevant to young survivors focused on oncofertility care. Notable approvals include hormone therapies such as tamoxifen and aromatase inhibitors (e.g., letrozole, anastrozole) for hormone receptor-positive breast cancer. Additionally, targeted therapies like trastuzumab for HER2-positive breast cancer and CDK 4/6 inhibitors (e.g., palbociclib) have been approved. These treatments aim to manage cancer while considering the patient's fertility goals, aligning with the objectives of improving engagement in goal-concordant oncofertility care.

What other types of research exist?

Promising novel alternatives for breast cancer patients considering treatment in 2024 include: 1) Biomarker-guided targeted therapies, which use specific biomarkers to tailor treatment plans, potentially improving outcomes and reducing side effects. 2) The use of dual inhibitors like lapatinib, which target multiple pathways involved in cancer progression. 3) Integration of oncofertility care with advanced reproductive technologies such as in vitro fertilization (IVF) and ovarian tissue cryopreservation, ensuring fertility preservation alongside cancer treatment. 4) Personalized medicine approaches that combine genetic profiling with individualized treatment plans to optimize both cancer care and fertility outcomes.

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Oncofertility Care Intervention for Young Breast Cancer Survivors

N/A

Recruiting

Led By H. Irene Su, MD, MSCE

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Breast cancer (Stages 0-IV) diagnosis

Be between 18 and 65 years old

Must not have

Women who are pregnant at recruitment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks after oncology visit

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of methods to help young breast cancer survivors get the fertility care that matches their personal goals. The study focuses on improving how these survivors engage with their fertility care. Researchers believe that using multiple strategies will help these patients receive the care they need.

Who is the study for?

This trial is for young women in Imperial County, California, who have been diagnosed with breast cancer (Stages 0-IV) and are not pregnant. They must speak English or Spanish and be receiving care at participating clinics.

What is being tested?

The study tests a multi-component intervention aimed at improving engagement in oncofertility care that aligns with the patient's reproductive goals after surviving breast cancer.

What are the potential side effects?

Since this is an intervention focused on healthcare engagement rather than medication, traditional side effects are not applicable. However, participants may experience emotional or psychological impacts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with breast cancer at any stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks after oncology visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks after oncology visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after oncology visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Medical record review of engagement in goal-concordant oncofertility care

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Multi-component oncofertility care interventionExperimental Treatment1 Intervention

After the intervention implementation, all breast cancer patients presenting to oncology clinical visits that meet eligibility criteria will receive the multi-component oncofertility care intervention.

Group II: Usual CareActive Control1 Intervention

Prior to the intervention implementation, all breast cancer patients presenting to oncology clinical visits that meet eligibility criteria will receive usual care.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Endocrine therapies, such as aromatase inhibitors and tamoxifen, are common treatments for hormone receptor-positive breast cancer. Aromatase inhibitors reduce estrogen levels by inhibiting the enzyme aromatase, while tamoxifen blocks estrogen receptors on cancer cells. These mechanisms are crucial as they help tailor treatments to individual tumor characteristics, improving patient outcomes and preserving fertility options.

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