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Chemotherapy
Chemotherapy + Endocrine Therapy for Breast Cancer (INSIGHT Trial)
Phase 2
Recruiting
Led By Sonya Reid, MD
Research Sponsored by Sonya Reid
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical stage IV invasive mammary carcinoma or unresectable locoregional recurrence of invasive mammary carcinoma that is ER/PR-positive (> 1% cells) by IHC and HER2 negative (by IHC or FISH)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
INSIGHT Trial Summary
This trial will evaluate if 2nd line chemo can improve survival in HR+ MBC patients.
Who is the study for?
This trial is for adults with HR+ metastatic breast cancer who have progressed after specific hormone therapies. They must be in good physical condition, have measurable disease, and their major organs need to function well. Pregnant women, those with recent radiation therapy or certain previous cancers are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of capecitabine chemotherapy on survival rates compared to standard endocrine therapy in patients whose tumors are non-Luminal A as determined by MammoPrint® and BluePrint® assays.See study design
What are the potential side effects?
Capecitabine can cause side effects like diarrhea, hand-foot syndrome (redness and pain in hands/feet), nausea, fatigue, low blood cell counts increasing infection risk; while endocrine therapy may lead to hot flashes, joint pain and osteoporosis.
INSIGHT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is advanced, ER/PR positive, and HER2 negative.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
Your blood counts, liver and kidney functions need to be at certain levels. Also, if you are in the randomized group, your tumor must be diagnosed as non-Luminal A using specific tests.
Select...
My cancer progressed after treatment with AI+CDK4/6 inhibitor or SERM/SERD+CDK4/6 inhibitor.
Select...
I am 18 years old or older.
INSIGHT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
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
Secondary outcome measures
Clinical Benefit Rate
Incidence of adverse events
Overall impact of treatment toxicity
+4 moreINSIGHT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Capecitabine_Non-Luminal A subtypesExperimental Treatment2 Interventions
Group II: Physician's Choice of Endocrine-based Therapy_Non-Luminal A subtypesActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3420
Find a Location
Who is running the clinical trial?
Sonya ReidLead Sponsor
AgendiaIndustry Sponsor
17 Previous Clinical Trials
39,056 Total Patients Enrolled
9 Trials studying Breast Cancer
34,729 Patients Enrolled for Breast Cancer
Susan G. Komen Breast Cancer FoundationOTHER
65 Previous Clinical Trials
217,124 Total Patients Enrolled
41 Trials studying Breast Cancer
215,072 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured or observed.My breast cancer is advanced, ER/PR positive, and HER2 negative.You have at least one lesion that can be measured according to specific guidelines. If you had radiation treatment to a lesion, it can only be counted as a measurable lesion if it has shown clear signs of getting worse after the treatment.I haven't had cancer other than breast cancer in the last 5 years, except for skin cancer, cervical pre-cancer, or low-risk cancers that were cured over 2 years ago.Your blood counts, liver and kidney functions need to be at certain levels. Also, if you are in the randomized group, your tumor must be diagnosed as non-Luminal A using specific tests.I have brain metastases but have been stable for over 4 weeks after radiation and am not on steroids.I have received chemotherapy for cancer that has spread.I have had more than one type of hormone therapy for my cancer.I have side effects from past treatments, but they are mild except for possible hair loss and mild nerve pain.I had radiation therapy more than 2 weeks ago and have recovered from its side effects, except for hair loss.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is in the bones but can be seen on scans.My cancer progressed after treatment with AI+CDK4/6 inhibitor or SERM/SERD+CDK4/6 inhibitor.My cancer has a PIK3CA mutation.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Physician's Choice of Endocrine-based Therapy_Non-Luminal A subtypes
- Group 2: Capecitabine_Non-Luminal A subtypes
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.
What hazards should be considered when using Capecitabine_Non-Luminal A subtypes?
"Our Power team gauged that Capecitabine_Non-Luminal A subtypes have a safety rating of 2 because this trial is in the Phase 2 stage, which implies there is some evidence for safety but no proof yet regarding efficacy."
Answered by AI
Are there still opportunities for enrolment in this research endeavor?
"As confirmed on clinicaltrials.gov, the current state of this trial does not involve patient recruitment; it was initially posted April 30th 2023 and last updated January 11th 2023. However, there are still 2249 other medical studies actively seeking participants at the moment."
Answered by AI
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