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Antibody-Drug Conjugate

Sacituzumab Govitecan + Talazoparib for Breast Cancer

Phase 1 & 2
Recruiting
Led By Aditya Bardia, MD, MPH
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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).Check my eligibility
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.See study design
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 below
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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 have not taken high doses of corticosteroids in the last 2 weeks.
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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-.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity
Secondary outcome measures
Duration of response
Overall Survival Rate
Progression-Free Survival
+1 more

Side effects data

From 2018 Phase 1 & 2 trial • 40 Patients • NCT02116777
89%
Anemia
78%
Alkaline phosphatase increased
78%
Nausea
78%
White blood cell decreased
67%
Fatigue
67%
Lymphocyte count decreased
56%
Aspartate aminotransferase increased
56%
Hypermagnesemia
56%
Headache
56%
Neutrophil count decreased
56%
Platelet count decreased
56%
Pain in extremity
44%
Constipation
44%
Hypoalbuminemia
44%
Non-cardiac chest pain
44%
Hyponatremia
33%
Creatinine increased
33%
Hypocalcemia
33%
Anorexia
33%
Back pain
33%
Diarrhea
33%
Alanine aminotransferase increased
33%
Alopecia
33%
Blood bilirubin increased
33%
Dizziness
33%
Fever
33%
Hyperglycemia
33%
Pain
33%
Proteinuria
33%
Sinus tachycardia
33%
Vomiting
22%
Cough
22%
Hypokalemia
22%
Abdominal pain
22%
Dyspnea
22%
Hypercalcemia
22%
Hypernatremia
22%
Hypophosphatemia
22%
Hypotension
22%
Hypoxia
22%
Nasal congestion
22%
Neck pain
11%
Allergic reaction
11%
Weight loss
11%
Tumor pain
11%
Febrile neutropenia
11%
Periorbital infection
11%
Eye disorders - Other, LEFT ORBITAL RECONSTRUCTION
11%
Edema limbs
11%
Irregular menstruation
11%
Bone pain
11%
Dysgeusia
11%
Hemoglobin increased
11%
Musculoskeletal and connective tissue disorder - Other, LARGE OCCIPITAL SKULL DEFECT
11%
Skin and subcutaneous tissue disorders - Other, ERYTHEMA
11%
Urinary urgency
11%
Renal and urinary disorders - Other, BLADDER PAIN
11%
Anxiety
11%
Avascular necrosis
11%
Depression
11%
Hypomagnesemia
11%
Respiratory, thoracic and mediastinal disorders - Other, OBSTRUCTIVE SLEEP APNEA
11%
Edema face
11%
Hematuria
11%
Lymphocyte count increased
11%
Activated partial thromboplastin time prolonged
11%
Cardiac disorders - Other, NON RESTRICTIVE CARDIOMYOPATHY
11%
Cystitis noninfective
11%
Epistaxis
11%
Gait disturbance
11%
Gastroesophageal reflux disease
11%
Hypertension
11%
Infections and infestations - Other, SHINGLES ZOSTER
11%
Insomnia
11%
Investigations - Other, BICARBONATE DECREASED
11%
Investigations - Other, BICARBONATE INCREASED
11%
Investigations - Other, BICARBONATE LOW
11%
Metabolism and nutrition disorders - Other, CHLORIDE LEVEL
11%
Mucosal infection
11%
Muscle weakness right-sided
11%
Pericardial effusion
11%
Pleural effusion
11%
Rash acneiform
11%
Respiratory, thoracic and mediastinal disorders - Other, ASTHMA
11%
Skin hyperpigmentation
11%
Skin ulceration
11%
Stomach pain
11%
Thromboembolic event
11%
Tinnitus
11%
Urinary retention
11%
Obesity
100%
80%
60%
40%
20%
0%
Study treatment Arm
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/doseBMN 673 BID+55mg/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+40mg/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 QD+20mg/m²/Dose TEM,Max 800 mcg/Day

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
Talazoparib
FDA approved

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,562 Previous Clinical Trials
10,906,901 Total Patients Enrolled
110 Trials studying Breast Cancer
35,174 Patients Enrolled for Breast Cancer
Massachusetts General HospitalLead Sponsor
2,924 Previous Clinical Trials
13,193,348 Total Patients Enrolled
80 Trials studying Breast Cancer
132,837 Patients Enrolled for Breast Cancer
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

Sacituzumab Govitecan (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04039230 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity of participants for this clinical study?

"Indeed, the clinicaltrials.gov records demonstrate that this research is presently recruiting participants. It was initially posted on October 9th 2019 and most recently updated on October 25th 2021. Seventy-five individuals are needed at a single medical centre for enrolment in this trial."

Answered by AI

Are there any past examinations that have focused on Talazoparib?

"Currently, 90 clinical trials are analyzing the utility of Talazoparib with 8 reaching Phase 3. Most investigations into its efficacy are being conducted in Boston, MA; however, there are 3725 separate medical centers that have joined this research effort."

Answered by AI

In what medical scenarios is Talazoparib utilized?

"Talazoparib is commonly prescribed to treat UC 84572, but can also benefit those with breast cancer linked to a BRCA1 gene mutation and/or previous platinum-based therapy."

Answered by AI

Are individuals being sought for enrollment in this clinical investigation?

"Affirmative. Querying clinicaltrials.gov yields that this medical trial, first posted on October 9th 2019, is currently recruiting participants - with the aim of finding 75 patients who will enrol at a single site."

Answered by AI
~14 spots leftby Mar 2025