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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival 1 (PFS1) Among Participants in Step 2
Secondary outcome measures
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 moreTrial 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
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
902 Previous Clinical Trials
409,576 Total Patients Enrolled
16 Trials studying Breast Cancer
1,051 Patients Enrolled for Breast Cancer
Frances Valdes-Albini, MDPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was treated with CDK4/6 inhibitors less than a year ago.My breast cancer is advanced but can still be treated with the goal of curing it.My electrolyte levels are stable and do not affect heart rhythm medications.My cancer has not spread to my organs in a way that threatens my life immediately.You have no detectable levels of ctDNA when you start the study.I am fully active or restricted in physically strenuous activity but can do light work.I am not pregnant or breastfeeding and using effective birth control if I can have children.I have a condition that affects how my body absorbs food.I don't have active brain metastases or symptoms from them.I am a woman who is postmenopausal, has suppressed ovarian function, or is premenopausal and willing to undergo hormone therapy for the trial.My breast cancer is ER positive, HER2 negative, and has spread.I have recovered from previous cancer treatment side effects, except for hair loss.I have a condition that causes abnormal bleeding.I haven't started hormone therapy for my cancer, or I started it less than 30 days ago.I haven't taken drugs affecting liver enzymes in the last week.I am 18 years old or older.I am allergic to certain breast cancer medications or their ingredients.I had stage II, III, or IV cancer within the last 5 years, but my breast cancer tumors were all ER+.I have a history of blood cancer.I have stored samples of my tumor.My tumor is HER2 positive or uncertain, based on specific tests.My breast cancer cannot be cured and has spread or come back.My cancer can be measured or evaluated by specific criteria.I haven't had major surgery or significant injury in the last 4 weeks.I have or am receiving treatment for another cancer, not including minor skin cancers or in situ cancers, within the last 2 years.I have not taken CDK 4/6 inhibitors for advanced cancer.I haven't had chemotherapy or targeted therapy for my advanced cancer.You are expected to live for more than three months.I need radiation for symptom relief soon or within 60 days after starting the trial.I cannot swallow pills.My organs and bone marrow are working well.
Research Study Groups:
This trial has the following groups:- Group 1: Step 2 Arm 1: No Modification of Therapy
- Group 2: Step 2 Arm 2: Early Switch in Therapy
- Group 3: Step 3: Optional Treatment for Patients in Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for individuals to participate in this experiment?
"As per the clinicaltrials.gov website, this medical experiment is not actively seeking participants at present. Initially posted on July 31st 2023 and last altered on April 12th of that same year, it has now ceased to recruit patients; however, there are currently 2,663 other trials accepting volunteers."
Answered by AI
To what extent does Step 2 Arm 1: No Modification of Therapy present a risk to participants?
"Considering the Phase 2 status of Step 2 Arm 1: No Modification of Therapy, its safety has been estimated to be a score of 2 as there is clinical evidence supporting it but none demonstrating efficacy."
Answered by AI
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