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Hormone Therapy

Hormonal Therapy for Early-Stage Breast Cancer

Phase 2

Recruiting

Research Sponsored by QuantumLeap Healthcare Collaborative

Eligibility Criteria Checklist

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

Must have

previous diagnosis of Hormone Receptor positive (HR+) DCIS (at least 50% ER or PR and 2+; biopsy will have been performed previously at diagnosis) with or without microinvasion

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if hormonal therapy & monitoring can manage early-stage breast cancer effectively. Participants get treatment & MRI exams, plus provide samples to study immune & genetic factors.

Who is the study for?

This trial is for women aged 18 or older who have been diagnosed with an early stage of breast cancer known as HR+ DCIS, which is hormone receptor positive. They must be willing to provide tumor samples and consent to participate in the study.

What is being tested?

The RECAST Trial is testing whether active surveillance combined with hormonal therapy can effectively manage ductal cell carcinoma in situ (DCIS). Participants will receive either standard hormonal treatments or investigational drugs and undergo MRI evaluations.

What are the potential side effects?

Potential side effects from the hormonal therapies may include hot flashes, mood swings, joint pain, fatigue, and a possible increased risk of other health issues like blood clots or bone thinning.

Eligibility Criteria

Inclusion Criteria

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

Select...

My previous cancer was hormone receptor positive with a biopsy confirming it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Patients remaining on active surveillance at 7 months

Secondary study objectives

Associate rate of progression to Invasive Ductal Carcinoma (IDC) with risk categorization after 6 months of treatment at 3 years

Change in artificial intelligence predicted risk based on mammography

Determine adherence to active surveillance protocol

+5 more

Other study objectives

Assess Germ Line polygenic risk: assess correlation of detectable mutations with endocrine response and qualification for active surveillance at 7 months

To evaluate outcomes stratified by immune and molecular subtype based upon multiplex immuno histochemistry (IHC) clustering analysis, and RPS expression array profiling

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Testosterone + Anastrazole (T+Ai)Experimental Treatment1 Intervention

White solid pellet for subcutaneous insertion consisting of 100mg Testosterone and 4mg Anastrazole, an aromatase inhibitor. A cylindrical pellet (4.5mm diameter, 6.35mm diameter) is inserted subcutaneously in the upper outer gluteal region or iliac fossa every 3 months, with treatment up to 36 months. There is active follow up with MRI at baseline, 3 months, 6 months after treatment initiation, and every 6 months alternating MRI and mammogram for up to 5 years. Participants are followed for an additional 5 years.

Group II: EndoxifenExperimental Treatment1 Intervention

(Z)-endoxifen is the most active metabolite of the selective estrogen receptor modulator (SERM), tamoxifen. Standard dose: 10mg PO delayed release capsule of z-endoxifen once daily for treatment up to 36 months. same time with a glass of water either 1 hour before a meal or 2 hours after a meal and should not take with alcohol. For patients on this arm there is active follow up with MRI at baseline, 3 months, 6 months after treatment initiation, and every 6 months alternating MRI and mammogram for up to 5 years. Participants are followed for an additional 5 years.

Group III: ElacestrantExperimental Treatment1 Intervention

Selective estrogen receptor degrader, Standard dose: 400mg PO with food once daily for treatment up to 36 months. Dose reduction of Elacestrant by up to 2 dose levels permitted depending on toxicity; 400 mg to 300 mg then 300 mg to 200 mg Participants requiring more than 2 dose reductions must discontinue treatment For patients on this arm there is active follow up with MRI at baseline, 3 months, 6 months after treatment initiation, and every 6 months alternating MRI and mammogram for up to 5 years. Participants are followed by for an additional 5 years.

Group IV: chemoprevention therapy per investigator choiceActive Control4 Interventions

a. For premenopausal women: 20 mg or 5 mg tamoxifen orally b. for postmenopausal women: standard oral doses of AI of choice: exemestane 25 mg daily, letrozole 2.5 mg daily, or anastrozole 1 mg daily; or reduced exemestane dosing: 25 mg 3 times per week orally i. For postmenopausal women who are not tolerating an AI, low dose (5 mg) or standard dose (20 mg) of tamoxifen There is active follow up with MRI at baseline, 3 months, 6 months after treatment initiation, and every 6 months alternating MRI and mammogram for up to 5 years. Participants may continue treatment for up to 5 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Elacestrant

2019

Completed Phase 3

~560

0 / 1Eligibility criteria met