What side effects are associated with this type of intervention?

Common treatments for breast cancer that involve ovarian function suppression, such as tamoxifen and aromatase inhibitors, have several known side effects. Tamoxifen can cause hot flashes, vaginal dryness or discharge, and an increased risk of blood clots and endometrial cancer. Aromatase inhibitors, like anastrozole, can lead to bone density loss, increased risk of fractures, joint pain, and cardiovascular issues. Both treatments may also cause fatigue and mood changes. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for hormone receptor-positive, HER2-negative breast cancer that involve ovarian function suppression. These include tamoxifen, which blocks estrogen receptors, and aromatase inhibitors such as letrozole, anastrozole, and exemestane, which reduce estrogen production. These treatments are often used in combination with ovarian suppression therapies to manage premenopausal women with breast cancer.

What other types of research exist?

Promising alternatives to TOL2506 for ovarian function suppression in breast cancer patients include tamoxifen and aromatase inhibitors (letrozole, anastrozole, exemestane). These are often used in combination with ovarian suppression methods. Additionally, keeping an eye on new clinical trials and emerging treatments in 2024 is advisable.

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Hormone Therapy

Ovarian Suppression Therapy for Breast Cancer (OVELIA Trial)

Phase 3

Recruiting

Led By E P Hamilton

Research Sponsored by Tolmar Inc.

Eligibility Criteria Checklist

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

Must have

Diagnosis of Stage I, II, or III HR+, HER2-negative breast cancer (ER>1% and/or, PR>1%, HER2-negative per ASCO CAP guidelines)

Age 18 to 49, inclusive

Must not have

Prior use of tamoxifen, other SERMs (eg, raloxifene) or antagonists (eg, fulvestrant), aromatase inhibitor, mammalian target of rapamycin (mTOR) inhibitors, or hormone replacement therapy within 3 months before breast cancer diagnosis

Prior (within 6 months prior to Day 1) or current use of drugs known to increase bone mineral density (ie, bisphosphonates, denosumab, teriparatide, abaloparatide, romosozumab) or use of supplements known to increase bone mineral density (ie, calcitonin, fluoride, strontium) within 28 days prior to Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks after the first administration of tol2506

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests TOL2506, a treatment that stops ovaries from working, in premenopausal women and men with hormone-sensitive breast cancer. It aims to reduce hormone levels to slow down or stop cancer growth. TOL2506 is a treatment that stops ovaries from working, similar to other ovarian suppression methods.

Who is the study for?

This trial is for premenopausal women aged 18-49 with HR+, HER2-negative breast cancer who are candidates for endocrine therapy and ovarian suppression. Men with the same cancer type may also participate. Participants must have normal liver, kidney function, and not be on certain medications or treatments that could interfere with the study.

What is being tested?

The effectiveness of TOL2506 in suppressing ovarian function alongside standard therapies (tamoxifen or aromatase inhibitors) is being tested over a 48-week period. The study will assess if this treatment can maintain low estradiol levels in women and testosterone levels in men.

What are the potential side effects?

Potential side effects include reactions to hormone injections like hot flashes, mood swings, changes in libido, injection site pain, as well as possible impacts on bone density and heart rhythm due to medication interactions.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is early to mid-stage, hormone receptor positive, and HER2 negative.

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I am between 18 and 49 years old.

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I am female.

Exclusion Criteria

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

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I haven't used tamoxifen, SERMs, aromatase inhibitors, mTOR inhibitors, or hormone therapy in the 3 months before my breast cancer diagnosis.

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I haven't taken drugs or supplements for bone density in the last 6 months.

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I have had a fracture from a fall at standing height or less, excluding fingers, toes, face, and skull, in the last year.

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My BMI is either below 18 or above 35.

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My liver is severely damaged.

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I cannot have a bone density scan due to surgery, metal in my body, or my weight.

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I am sexually active and not planning to use non-hormonal birth control during the study.

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I need help with my daily activities due to my health condition.

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My kidney function is reduced and I have low bone density.

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My kidney function is low, with a creatinine clearance of 30 mL/min or less.

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I have been treated for weak bones or have a low bone density score.

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I am not taking any cancer medications not approved by this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks after the first administration of tol2506

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks after the first administration of tol2506

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks after the first administration of tol2506 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Suppression of ovarian function

Secondary study objectives

Suppression of ovarian function overall (LH, E2, menses; TOL2506 + tamoxifen)

Suppression of ovarian function overall (LH, E2, menses; treatments pooled)

Suppression of ovarian function overall (LH, E2; TOL2506 + aromatase inhibitor)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Active Comparator: TOL2506Experimental Treatment5 Interventions

TOL2506 in combinatination with standard endocrine therapy (Tamoxifen \& Aromatase Inhibitors)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tamoxifen

2005

Completed Phase 4

~30110

0 / 15Eligibility 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

Common treatments for breast cancer, particularly in premenopausal women with hormone receptor-positive (HR+), HER2-negative disease, often involve ovarian function suppression to reduce estrogen production, which fuels cancer growth. TOL2506, for example, is used to achieve this suppression. Other treatments include tamoxifen, which blocks estrogen receptors on cancer cells, and aromatase inhibitors (AIs) like letrozole, anastrozole, and exemestane, which lower estrogen levels by inhibiting the enzyme aromatase. These therapies are essential as they target the hormonal pathways that promote cancer cell growth, thereby slowing disease progression and improving survival outcomes.

Impact of ovarian function suppression in premenopausal women with estrogen receptor-positive early breast cancer.Adjuvant therapy for premenopausal patients with early breast cancer.