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PD-L1 Inhibitor
Talazoparib + Atezolizumab + Radiation for Metastatic Triple Negative Breast Cancer (TARA Trial)
Phase 2
Waitlist Available
Led By Mylin Torres, MD
Research Sponsored by Mylin A. Torres, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to a maximum of 12 months.
Awards & highlights
TARA Trial Summary
This trial is testing a new combination of treatments for triple negative breast cancer that is positive for PD-L1. Up to 23 people will be enrolled, and they will receive a pill (talazoparib), high-dose radiation, and an intravenous infusion (atezolizumab) according to a schedule. The goal is to see if this is an effective and safe treatment.
Eligible Conditions
- Breast Cancer
TARA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to a maximum of 12 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to a maximum of 12 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) by RECIST 1.1
Secondary outcome measures
Assess Adverse Events
Best Overall Tumor Response
Disease Control Rate (DCR)
+5 moreSide effects data
From 2018 Phase 1 & 2 trial • 40 Patients • NCT0211677789%
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%
Hypokalemia
22%
Cough
22%
Abdominal pain
22%
Dyspnea
22%
Hypercalcemia
22%
Hypernatremia
22%
Hypophosphatemia
22%
Hypotension
22%
Hypoxia
22%
Nasal congestion
22%
Neck pain
11%
Weight loss
11%
Periorbital infection
11%
Bone pain
11%
Allergic reaction
11%
Tumor pain
11%
Febrile neutropenia
11%
Eye disorders - Other, LEFT ORBITAL RECONSTRUCTION
11%
Edema limbs
11%
Irregular menstruation
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
TARA Trial Design
1Treatment groups
Experimental Treatment
Group I: Study Treatment ArmExperimental Treatment3 Interventions
All patients will be treated with induction talazoparib of 1mg PO daily starting Day 1. Patients will then receive 8 Gy x 3 fractions to 1-4 metastatic lesions beginning Day 12,13, or 14 and given QOD. 840 mg of atezolizumab will be given intravenously (IV) on Day 15 of the 1st cycle and then on Day 1 and Day 15 of the remaining cycles. The sequence of administration is not specified on the days in which talazoparib and atezolizumab are given on the same day. Each cycle equals 28 days. Treatment will continue until progression or severe toxicity.
A safety lead in of up to 6 patients will be performed. Immune-related and non-immune related adverse events will be tracked up to 12 weeks post initiation of atezolizumab, as the majority of treatment-related toxicities from talazoparib, radiation, and atezolizumab occur within this time period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
2021
Completed Phase 2
~2770
Atezolizumab
2017
Completed Phase 3
~5860
Radiation
2003
Completed Phase 3
~1020
Find a Location
Who is running the clinical trial?
Mylin A. Torres, MDLead Sponsor
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,142 Total Patients Enrolled
96 Trials studying Breast Cancer
23,217 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,916,025 Total Patients Enrolled
111 Trials studying Breast Cancer
36,443 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a known gBRCA 1/2 status, but if you are gBRCA 1/2 negative (for example, gBRCA wild-type or gBRCA variants of uncertain significance), you can participate.You have serious health conditions like severe heart failure or recent heart attack.You have received certain types of cancer treatments within a specific time period, or have not fully recovered from any side effects caused by these treatments.You have a specific genetic mutation in the BRCA1 or BRCA2 genes.You have already received four or more rounds of a specific type of chemotherapy for metastatic triple-negative breast cancer.You have received radiation treatment on the areas that will be treated with radiation in this study before.Your breast cancer got worse within 3 months of trying immune therapy.You are able to perform daily activities and have a good level of energy for daily tasks.You have been diagnosed with metastatic triple negative breast cancer and have at least 2 areas of cancer spread outside the brain as shown on imaging tests.Your tumor has a certain level of PD-L1 protein as measured by a specific test.You are currently taking steroids or medicines that weaken your immune system.You have a history of leptomeningeal disease.You have received treatment with PARP inhibitors like talazoparib, niraparib, or olaparib before.You currently have a serious bacterial or fungal infection that needs to be treated with IV antibiotics.You have a serious lung condition that required a hospital stay when you enrolled in the study.You have HIV and your CD4 count is less than 200 cells per microliter.You are currently using hormone replacement therapy.You have another type of cancer that is getting worse or needs treatment, except for certain types of skin cancer that have been treated successfully, or slow-growing cancers that are not being treated.You must have at least one cancerous growth outside the brain that can be treated with high-dose radiation, and another measurable cancerous growth that will not be treated with radiation. If the lesions are in the same organ, they must be at least 2 centimeters apart.You cannot receive any other cancer treatment while participating in this study, except for specific medications and therapies mentioned in the criterion.You have had an autoimmune disease that needed strong medication to treat it.You have received no more than three previous treatments for your advanced cancer, and at least one of them did not include targeted small molecules, hormonal agents, or certain monoclonal antibodies. If you had chemotherapy for advanced cancer, you must wait at least 2 weeks before starting the new treatment. If you had radiotherapy or chemotherapy for non-metastatic breast cancer, you must wait 2 weeks after your last treatment before starting this study.You have a brain or spinal cord condition that has not been treated. However, if your condition has been stable for at least 28 days or you have asymptomatic treated brain or spinal cord spread of cancer, you may still be eligible.
Research Study Groups:
This trial has the following groups:- Group 1: Study Treatment Arm
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.
To your knowledge, are there other similar trials to this one?
"Talazoparib has been the focus of medical research since 2008. A study completed that year, which was sponsored by Hoffmann-La Roche, found enough evidence to support taking Talazoparib to Phase 2 drug approval. As of now, there are 408 active studies being conducted in 75 countries and 1842 cities."
Answered by AI
Can you give some background on other times Talazoparib has been tested in a clinical setting?
"Out of the total 408 studies on Talazoparib, 75 are currently in Phase 3. Most of these trials take place in Duarte, California; though, there are 20,520 locations running clinical trials for this potential treatment."
Answered by AI
Has the FDA given Talazoparib their blessing?
"While Phase 2 trials don't have the same level of data supporting efficacy, our team has rated Talazoparib a 2 in terms of safety."
Answered by AI
What are the most popular indications for Talazoparib?
"Talazoparib is a medication that is most commonly used as part of pharmacotherapy. It has also been shown to be effective in treating malignant neoplasms, small cell lung cancer (sclc), and non-small cell lung carcinoma."
Answered by AI
Are people still being signed up for this experiment?
"The clinicaltrials.gov website reveals that this trial is still recruiting patients, with the first posting on April 1st, 2021 and the most recent update on September 12th, 2022."
Answered by AI
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