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New treatment option for Breast Cancer
Official title Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial
ClinicalTrials.gov ID: NCT03990896
What this study is testing
What is Talazoparib?
Talazoparib is an investigational medicine, being studied as a potential treatment for breast cancer.
Also referred to as Talzenna.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This research is to evaluate the effectiveness of Talazoparib as a potential treatment for metastatic breast cancer with a BRCA 1 or BRCA 2 mutation.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Metastatic breast cancer with deleterious somatic BRCA 1 or 2 mutations detectable by cell-free circulating tumor DNA, by CLIA certified clinical...
- Patients with germline BRCA 1 or 2 mutations will not be eligible.
- Patients with only a VUS (Variant of Unknown Significance), or non-functional BRCA mutation, without a deleterious somatic BRCA 1 or 2 mutation will...
- The following disease subtypes are eligible:
- Triple negative breast cancer (defined as ER \< 1%, PR \< 1%, HER2 negative, as per ASCO CAP guidelines), with disease progression on at least one...
You likely can't join if
- Treatment with an investigational agent within 4 weeks of the first dose of treatment.
- Patients must not have received prior treatment with a PARP inhibitor
- Patients must not have a germline BRCA 1 or 2 mutation
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e...
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous...
- Has known, untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.
See the full eligibility criteria
- Metastatic breast cancer with deleterious somatic BRCA 1 or 2 mutations detectable by cell-free circulating tumor DNA, by CLIA certified clinical assay (including but not restricted to MGH-Snapshot cfDNA assay...
- Patients with germline BRCA 1 or 2 mutations will not be eligible.
- Patients with only a VUS (Variant of Unknown Significance), or non-functional BRCA mutation, without a deleterious somatic BRCA 1 or 2 mutation will not be eligible.
- The following disease subtypes are eligible:
- Triple negative breast cancer (defined as ER \< 1%, PR \< 1%, HER2 negative, as per ASCO CAP guidelines), with disease progression on at least one prior chemotherapy regimen in the metastatic setting.
- Hormone receptor positive, HER2 negative disease with disease progression on at least one prior endocrine therapy in the metastatic setting or be considered inappropriate for endocrine therapy
- Patients must have evaluable or measurable disease.
- Any number of prior lines of therapy are allowed
- Patients may have received prior platinum based chemotherapy (0-1 prior platinum based therapy). However, the patient must not have progressed while on platinum treatment (any setting), or within 6 months after end of...
- At least two weeks from last systemic therapy for breast cancer, with recovery of all treatment related toxicity to grade 1 or less. people with ≤ Grade 2 neuropathy are an exception to this criterion.
- At least two weeks from last radiation therapy, with recovery of all treatment related toxicity to grade 1 or less. -≥ 18 years of age on day of signing informed consent.
- ECOG performance status of ≤2.
- Adequate organ function as defined in Table 1 within 10 days prior to treatment initiation.
- Adequate Organ Function Laboratory Values
- SYSTEM LABORATORY VALUE
- Hematological
- Absolute neutrophil count (ANC) ≥1,500 /mcL
- Platelets ≥100,000 / mcL
- Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)
- Renal --Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 X institutional upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine...
- Hepatic
- Serum total bilirubin ≤ 1.5 X institutional ULN OR Direct bilirubin ≤ institutional ULN for people with total bilirubin levels \> 1.5 ULN
- AST (SGOT) and ALT (SGPT) ≤ 2.5 X institutional ULN OR ≤ 5 X institutional ULN for people with liver metastases
- Prior CNS disease is allowed if stable for at least one month since whole brain radiation therapy in patients who received whole brain radiation, or 2 weeks since stereotactic radiotherapy in patients who received...
- Female people of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as...
- Female people of childbearing potential must use an acceptable form of birth control per treating physician discretion or be surgically sterile, or abstain from heterosexual activity for the course of the study through...
- Male people should agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy. Additionally, male patients may not donate sperm...
- Willing and able to provide written informed consent.
- Treatment with an investigational agent within 4 weeks of the first dose of treatment.
- Patients must not have received prior treatment with a PARP inhibitor
- Patients must not have a germline BRCA 1 or 2 mutation
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously...
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative...
- Has known, untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is...
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 7 months after the last dose of trial treatment.
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has known active Hepatitis B or Hepatitis C.
- Patients should not be on strong P-glycoprotein inhibitors.
- Patients should not be on any other anti-cancer therapy (chemotherapy, hormone therapy, immunotherapy, or alternate investigational therapy).
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; New York, New York, United States; Nashville, Tennessee, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.