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Antibody-Drug Conjugate
Sacituzumab Govitecan + Talazoparib for Breast Cancer
Phase 1 & 2
Recruiting
Led By Laura Spring, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has adequate bone marrow and organ function as defined by specific laboratory values at screening
Histologically confirmed stage IV (metastatic) breast cancer
Must not have
Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
Participants who have received prior irinotecan or ADC backbone with SN-38 or topoisomerase-1 inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
This trial is testing a new combination therapy for metastatic triple-negative breast cancer.
Who is the study for?
This trial is for adults with stage IV breast cancer that hasn't spread to the brain, who haven't had recent cancer treatments or surgeries, and are not pregnant. They must have a certain level of health, including stable blood sugar levels and an ECOG performance status of 0-1 (fully active or restricted in physically strenuous activity but ambulatory).
What is being tested?
The study tests Sacituzumab Govitecan combined with Talazoparib in patients with metastatic triple-negative breast cancer. It aims to see how well these drugs work together against this aggressive form of cancer.
What are the potential side effects?
Possible side effects include nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, hair loss, neuropathy (nerve pain or tingling), and potential allergic reactions to the drug components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood tests show my organs and bone marrow are working well.
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My breast cancer has spread to other parts of my body.
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I am 18 years old or older.
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I am a woman, regardless of my menopause status.
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I finished my cancer treatment or major surgery at least 2 weeks ago and have recovered.
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I am fully active or can carry out light work.
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My breast cancer is ER-, PR-, and HER2-.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have uncontrolled heart problems or abnormal heart rhythms.
Select...
I have previously been treated with irinotecan or similar drugs.
Select...
My cancer has spread to my brain and is getting worse.
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I am HIV-positive and on combination antiretroviral therapy.
Select...
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2018 Phase 1 & 2 trial • 40 Patients • NCT02116777100%
Fatigue
100%
Headache
67%
Platelet count decreased
67%
Hyperglycemia
67%
Anemia
67%
Back pain
33%
Lymphocyte count decreased
33%
Fever
33%
Nervous system disorders - Other, PARALYSIS
33%
Pain in extremity
33%
Weight loss
33%
Hyponatremia
33%
Hypoglycemia
33%
Neutrophil count decreased
33%
White blood cell decreased
33%
Skin infection
33%
Hypokalemia
33%
Peripheral motor neuropathy
33%
Insomnia
33%
Sinus tachycardia
33%
Creatinine increased
33%
Alanine aminotransferase increased
33%
Peripheral sensory neuropathy
33%
Diarrhea
33%
Hypermagnesemia
33%
Constipation
33%
Hypophosphatemia
33%
Gastroesophageal reflux disease
33%
Skin ulceration
33%
Muscle weakness lower limb
33%
Cough
33%
Non-cardiac chest pain
33%
Scoliosis
33%
Urinary incontinence
33%
Nystagmus
33%
Arthralgia
33%
Gait disturbance
33%
Edema limbs
33%
Hypertension
33%
Chills
33%
Investigations - Other, AST DECREASED
33%
Nervous system disorders - Other, HYPOTONIC
33%
Alopecia
33%
Aspartate aminotransferase increased
33%
Blurred vision
33%
Investigations - Other, ALT DECREASED
33%
Hypothyroidism
33%
Nausea
33%
Investigations - Other, BUN DECREASED
33%
Alkaline phosphatase increased
33%
Neuralgia
33%
Skin and subcutaneous tissue disorders - Other, LEFT LOWER LEG ERYTHEMA
33%
Anorexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day
600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day
400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day
600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Sacituzumab Govitecan+TalazoparibExperimental Treatment2 Interventions
* Sacituzumab Govitecan is administered on days 1 and 8 of a 21 day cycle.
* Talazoparib is administered daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab govitecan
FDA approved
Talazoparib
FDA approved
Find a Location
Who is running the clinical trial?
PfizerIndustry Sponsor
4,675 Previous Clinical Trials
28,717,106 Total Patients Enrolled
114 Trials studying Breast Cancer
41,308 Patients Enrolled for Breast Cancer
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,745 Total Patients Enrolled
79 Trials studying Breast Cancer
131,096 Patients Enrolled for Breast Cancer
Laura Spring, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
260 Total Patients Enrolled
Aditya Bardia, MD, MPHPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital, Massachusetts General Physicians Organization Inc
All India Inst Of Medical Sci (Medical School)
Mayo Grad School Med/Mayo Fndn (Residency)
2 Previous Clinical Trials
1,335 Total Patients Enrolled
1 Trials studying Breast Cancer
1,075 Patients Enrolled for Breast Cancer
Media Library
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.