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Berzosertib + Radiation for Triple-Negative Breast Cancer
Phase 1
Waitlist Available
Led By Robert W Mutter
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has undergone total mastectomy or wide local excision with axillary staging, and the margins of the resected wide local excision or mastectomy specimens are free of invasive tumor and ductal carcinoma in situ (DCIS) or patient has undergone axillary surgery for regionally recurrent breast cancer. Unresected axillary level III, internal mammary, and supraclavicular nodal disease is permitted.
Creatinine =< 1.1 mg/dL OR Glomerular filtration rate (GFR) >= 45 mL/min/1.73 m^2 for patients with creatinine levels above 1.1 mg/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a new drug, berzosertib, to see if it's effective in treating triple negative breast cancer. The drug is given with radiation therapy, and the hope is that it will kill more tumor cells than radiation therapy alone.
Who is the study for?
Adults over 18 with certain types of breast cancer (triple-negative or hormone receptor-positive, HER2-negative) that didn't respond to chemotherapy can join. They must have completed surgery and possibly postoperative chemo recently, be in good health otherwise, and agree to use contraception. People with recent chemo, prior radiation in the same area, uncontrolled illnesses, or known hypersensitivity to similar drugs are excluded.Check my eligibility
What is being tested?
The trial is testing Berzosertib combined with standard radiation therapy against breast cancer that resisted chemotherapy. It aims to find the best dose of Berzosertib which blocks enzymes needed for cell growth and may enhance the effectiveness of radiation therapy.See study design
What are the potential side effects?
Potential side effects include reactions related to DNA repair inhibition which could affect cell growth leading to fatigue, digestive issues or blood disorders. Specific side effects from combining Berzosertib with radiation aren't fully known but will be monitored closely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had breast surgery with clear margins, or surgery for recurrent breast cancer with some untreated areas allowed.
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My kidney function is normal or only slightly impaired.
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I can take care of myself but might not be able to do heavy physical work.
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My surgical wound has fully healed without any infection.
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I am 18 years old or older.
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I had hepatitis C but am now cured, or I am being treated with no detectable virus.
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I am getting radiation therapy for breast cancer, including the chest wall and nearby lymph nodes, on one side only.
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My hepatitis B virus is under control with treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended phase II dose of berzosertib
Secondary outcome measures
Change in patient-related outcomes (PRO)
Disease-free survival (DFS)
Distant DFS
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (berzosertib, radiation therapy)Experimental Treatment5 Interventions
Patients receive berzosertib IV over 60 minutes BIW for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo RT 5 days a week for 5-6 weeks depending on the type of surgery undergone. Patients also undergo a collection of blood on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Berzosertib
2021
Completed Phase 2
~80
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,111 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Robert W MutterPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
1 Previous Clinical Trials
88 Total Patients Enrolled
1 Trials studying Breast Cancer
88 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had immediate reconstruction after my mastectomy.My breast cancer is triple-negative or has low hormone receptor levels, and I've had specific chemotherapy.I have recovered from previous cancer treatment side effects, except for hair loss and mild nerve pain.I have not had chemotherapy in the last 4 weeks.You had allergic reactions to drugs similar to berzosertib.I am not pregnant or able to become pregnant, and will use birth control during and after the study.I have had cancer before, but it was either skin cancer that wasn't melanoma or a non-invasive type that didn't affect my current treatment.Your platelet count is within the normal range for the specific medical facility.I had breast surgery with clear margins, or surgery for recurrent breast cancer with some untreated areas allowed.My kidney function is normal or only slightly impaired.I can take care of myself but might not be able to do heavy physical work.I have lupus, scleroderma, or dermatomyositis with high CPK levels.I am not taking any strong medication that affects how drugs are processed in my body.I finished my last breast surgery or chemotherapy between 21 to 90 days ago.My surgical wound has fully healed without any infection.I am 18 years old or older.Your white blood cell count is normal or higher.I had hepatitis C but am now cured, or I am being treated with no detectable virus.Your white blood cell count is within a certain range.I am not on any experimental drugs but can be on hormone therapy or bisphosphonates.I am not pregnant or breastfeeding.I am getting radiation therapy for breast cancer, including the chest wall and nearby lymph nodes, on one side only.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.My hepatitis B virus is under control with treatment.I have had radiation therapy on the same side as my current breast or chest cancer.I do not have any serious ongoing illnesses that are not under control.I do not have genetic conditions like Li Fraumeni syndrome that make me extra sensitive to radiation, but I may have mutations in genes like BRCA1 or BRCA2.Your total bilirubin level is not higher than 1.5 times the normal limit at the study site.I have breast cancer and received anthracycline or taxane before surgery, regardless of the number of treatments.Your AST and ALT levels in your blood should not be more than three times the normal limit.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (berzosertib, radiation therapy)
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.
Is enrollment still open for this investigation?
"According to the data on clinicaltrials.gov, this ongoing trial is actively seeking participants. Its inception was noted as November 20th 2019, with recent updates being done on November 22nd 2022."
Answered by AI
Has Berzosertib been given the green light by the Food and Drug Administration?
"Our analysis yields a score of 1 for Berzosertib's safety, since this trial is still in Phase 1 and there has not been sufficient data collected to support its efficacy or security."
Answered by AI
Are multiple medical facilities administering this clinical trial within the city limits?
"This trial is offered at 11 sites, including the University of Utah Sugarhouse Health Center in Salt Lake City, Mayo Clinic Arizona in Scottsdale and Rochester in Minnesota. In addition to these three locations there are 8 other centres that provide this medical treatment."
Answered by AI
Could you summarize any other investigations that have utilized Berzosertib?
"Currently, 15 trials are underway exploring the efficacy of Berzosertib with none currently at Phase 3. 277 sites around the world have operational tests for this medication, including several in Sacramento, California."
Answered by AI
Could you provide an estimate of the size of the patient cohort involved in this research project?
"In order for this trial to be successful, a total of 42 individuals meeting the pre-determined inclusion criteria must join. Potential participants will find study locations at University of Utah Sugarhouse Health Center in Salt Lake City and Mayo Clinic in Arizona located in Scottsdale, Minnesota."
Answered by AI
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