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Hormone Therapy

Early Treatment Switch Strategies for Advanced Breast Cancer

Phase 2

Recruiting

Led By Frances Valdes-Albini, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

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

Must have

Patients with a diagnosis of ER+, HER2- metastatic (Stage IV) breast cancer. Positivity status is defined as >10% staining for ER and immunohistochemistry (IHC) 0+ or IHC 1 or 2+ staining for HER-2, and fluorescence in situ hybridization (FISH) negative with standard pathology staining methods

No visceral crisis. Visceral crisis is defined as advanced, symptomatic, visceral spread that is at risk of life-threatening complication in the short term and that requires chemotherapy

Must not have

Locally advanced breast cancer or locoregional relapse amenable for any treatment with curative intent

Uncontrolled electrolyte disorders that can compound the effects of a QTc prolonging drug (eg, hypocalcemia, hypokalemia, hypomagnesaemia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if treating metastatic breast cancer earlier can help patients live longer.

Who is the study for?

This trial is for men and women over 18 with advanced breast cancer that can't be cured by surgery. They must have hormone receptor positive, HER2- metastatic breast cancer, no prior treatment for advanced disease, and their body should be functioning well enough to participate. Patients who've had certain other cancers or treatments recently aren't eligible.

What is being tested?

The study tests if switching breast cancer treatments when a blood marker (ctDNA) indicates the disease is progressing—before it's visible on scans—helps control the cancer longer. It compares early switchers to those who change treatments later based on standard methods like imaging results.

What are the potential side effects?

Potential side effects from the drugs being tested include hormonal changes due to estrogen blockers, immune system effects from mTOR inhibitors, digestive issues from PI3K inhibitors, and common chemotherapy side effects like fatigue, nausea, hair loss, and increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is ER positive, HER2 negative, and has spread.

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My cancer has not spread to my organs in a way that threatens my life immediately.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have stored samples of my tumor.

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My cancer can be measured or evaluated by specific criteria.

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I haven't had chemotherapy or targeted therapy for my advanced cancer.

Exclusion Criteria

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

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My breast cancer is advanced but can still be treated with the goal of curing it.

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My electrolyte levels are stable and do not affect heart rhythm medications.

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I have a condition that affects how my body absorbs food.

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I have a condition that causes abnormal bleeding.

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I haven't taken drugs affecting liver enzymes in the last week.

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I am allergic to certain breast cancer medications or their ingredients.

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I have a history of blood cancer.

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My tumor is HER2 positive or uncertain, based on specific tests.

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I have not taken CDK 4/6 inhibitors for advanced cancer.

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I need radiation for symptom relief soon or within 60 days after starting the trial.

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I cannot swallow pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression-Free Survival 1 (PFS1) Among Participants in Step 2

Secondary study objectives

Clinical Benefit Rate (CBR)

Median time from enrollment to rise in ctDNA ratio > 1 for Participants in Step 1

Number of participants in Step 1 with rising ctDNA ratio > 1

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Step 3: Optional Treatment for Patients in Arm 1Experimental Treatment9 Interventions

Optional for participants who were randomized to Step 2 Arm 1 and experience clinical progression. Participants may change from their AI+CDK4/6i to SERD+CDK4/6i, or from SERD+CDK4/6i treatment to alternative endocrine therapy or chemotherapy. Therapy options for Step 3 are the same as listed for participants randomized to Step 2 Arm 2 and is administered standard of care. For those patients who decline to crossover into Step 3, further treatment and disease management will occur at their treating physician's discretion.

Group II: Step 2 Arm 2: Early Switch in TherapyExperimental Treatment9 Interventions

Participants in Step 2 Arm 2 undergo an early switch in standard of care therapy received in Step 1: * From AI+CDK4/6i in Step 1 to one of the following alternate endocrine therapies (ET) or chemotherapy: * SERD+CDK4/6i * mTOR Inhibitor + AI * mTOR Inhibitor+SERD * mTOR inhibitor + Selective estrogen receptor modulator * PI3K inhibitor + SERD * oral SERD * Chemotherapy * From SERD+CDK4/6i in Step 1 to one of the following alternate ET or chemotherapy: * mTOR Inhibitor + AI * mTOR Inhibitor+SERD * mTOR inhibitor + Selective estrogen receptor modulator * PI3K inhibitor + AI * PI3K inhibitor + SERD * oral SERD * Chemotherapy Participants will receive this therapy for approximately 14 months.

Group III: Step 2 Arm 1: No Modification of TherapyExperimental Treatment2 Interventions

Participants in Step 2 Arm 1 will first undergo ctDNA monitoring in Step 1, providing blood samples for ctDNA testing at the following timepoints until a rise in ctDNA leading to a ratio (ctDNA result at time of assessment/ctDNA level at baseline) greater than (\>) 1 occurs: * Cycle 1 day 1 (C1D1), * Day 30 (D30) post-treatment initiation (±3 days), * Day 60 (D60) post-treatment initiation (±3 days), and then * every 8-9 weeks (±1 week). Participants will have no change in standard of care therapy administered in Step 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chemotherapy

2003

Completed Phase 4

~3050

0 / 17Eligibility criteria met