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Breast CancerPhase 1/2NCT03964532

TALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer

A Phase 1/2 study testing Talazoparib and Avelumab in people with Breast Cancer, run by Georgetown University at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a multi-institutional pilot trial for patients with advanced breast cancer. The trial is designed to assess the safety and tolerability of induction talazoparib followed by combination of talazoparib and avelumab. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Talazoparib and Avelumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesUnited States
Study dates
19 Apr 2019to Apr 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed advanced breast cancer not amenable to curative treatment by surgery or radiotherapy, that is amenable to biopsy
  • Radiographically measurable disease by RECIST v1.1
  • Age ≥ 18 years
  • Life expectancy of more than 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  • Signed informed consent form
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  • Patients with a standard 12-lead electrocardiogram (ECG) with the following parameters at screening (defined as the mean of the triplicate ECGs):
  • QTc interval at screening < 481 msec
  • Resting heart rate 50-100bpm
  • Adequate hepatic, bone marrow, and renal function at the time of enrollment:
  • Bone Marrow: Absolute neutrophil count (ANC) ≥ 1,500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 9.0 g/dL. Patients must be able to meet the criteria without transfusion or receipt of colony stimulating factors within 2 weeks before obtaining sample
  • Creatinine clearance ≥ 60 mL/min based on Cockcroft-Gault equation
  • Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × the upper normal limit of institution's normal range. Total bilirubin ≤ 1.5 × the upper normal limit of institution's normal range, except for subjects with documented history of Gilbert's syndrome who may enroll at Investigator discretion. For subjects with liver metastases, AST and ALT < 5 × the upper normal limit of institution's normal range, and total bilirubin >1.5 - 3.0 x the upper normal limit of institution's normal range are acceptable as long as there is no persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia
  • Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) must be ≤ 2 X the upper limit of the institution's normal range and International Normalized Ratio (INR) < 2. Subjects on anticoagulation (such as coumadin) will be permitted to enroll as long as the INR is in the acceptable therapeutic range as determined by the investigator
  • Patients may have received an unlimited number of prior therapies. The last dose of systemic therapy must have occurred a minimum of 2 weeks prior to C1D1.
  • Patients must have fully recovered from all effects of surgery. Patients must have had at least two weeks after minor surgery and four weeks after major surgery before starting therapy. Minor procedures requiring conscious sedation such as endoscopies or mediport placement may only require a 24-hour waiting period, but this must be discussed with an investigator
  • Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
  • Patient is capable of swallowing pills whole
  • Subject, or legally authorized representative (LAR) is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent, approved by the IRB, prior to the initiation of any screening or study-specific procedures
  • Patient, or LAR, must consent to multiple biopsies during study.

Who cannot join

  • Prior disease progression while receiving anti-PD-1 or anti-PD-L1 therapy within 6 months of use
  • Prior exposure to PARP inhibitor-based therapy
  • Patients with known untreated central nervous system (CNS) metastases
  • Recent severe infection or antibiotic use, or known chronic infection with human immunodeficiency virus (HIV) or hepatitis B virus
  • Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
  • Diagnosis of immunodeficiency or is receiving systemic steroid or other immunosuppressive therapy
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  • Active autoimmune disease that has required systemic treatment in the past 2 years
  • History of tuberculosis
  • History of allogenic bone marrow transplant or solid organ transplant
  • History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest CT scan
  • Life-threatening visceral disease or other severe concurrent disease that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol
  • Live vaccine administration within 30 days of planned start of study therapy
  • Cardiovascular disease problems including unstable angina, therapy for lifethreatening ventricular arrhythmia, or myocardial infarction, stroke within the last 6 months, or a diagnosis of congestive heart failure
  • Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs
  • Presence of a psychiatric illness or social situation that would limit compliance with study requirements
  • Women who are pregnant or breastfeeding
  • Patients with history of another active malignancy within the past 2 years, excluding non-melanoma carcinoma of the skin
  • Patients receiving any other investigational agents
  • Patients must not have had radiotherapy encompassing >20% of the bone marrow
  • Patients must not have current evidence of any condition, therapy, or laboratory abnormality (including active or uncontrolled myelosuppression [ie, anemia, leukopenia, neutropenia, thrombocytopenia]) that might confound the results of the study or interfere with the patient's participation for the full duration of the study treatment or that makes it not in the best interest of the patient to participate
  • Patients must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection.
  • Current use of potent P-gp inhibitors within 7 days prior to randomization.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Utah, Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: TALAVE: A Pilot Trial of Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer

This is a multi-institutional pilot trial for patients with advanced breast cancer. The trial is designed to assess the safety and tolerability of induction talazoparib followed by combination of talazoparib and avelumab. As an exploratory endpoint, the study team will evaluate the immunomodulatory effects of induction talazoparib followed by the combination of talazoparib and avelumab in patients with advanced breast cancer.

Conditions
Breast Cancer
Being tested
Talazoparib, Avelumab
Keywords
Breast Cancer, Advanced Breast Cancer, Talazoparib, Avelumab
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TalazoparibDrug

    Also called Talzenna

    Talazoparib (formerly MDV3800 and BMN673) is an oral small molecule, selective inhibitor of PARP-1 and PARP-2.

  • AvelumabDrug

    Also called Bavencio

    Avelumab (formerly MSB0010718C) is a human immunoglobulin G1 (IgG1) anti-PD-L1 monoclonal antibody131 that utilizes both adaptive and innate immune mechanisms.

Study groups in NCT03964532
Study groupRoleWhat they receive
Phase I/Phase IIExperimentalTalazoparib (1mg by mouth [PO] daily D1-28) will be provided as monotherapy for the first cycle. Starting with cycle 2 and for all subsequent cycles, treatment with avelumab (800 mg intravenously [IV] D1 every 2 weeks) will be added to talazoparib.
Receives: Drug: Talazoparib; Drug: Avelumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quantification of Grade 3 and 4 toxicities (Adverse Events)

    Quantification of grade 3 and 4 toxicities according to the National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 [NCI CTCAE v4.03]. Toxicity analysis will be conducted in all patients receiving at least one dose of talazoparib.

    Measured: from the start of study drugs through 30 days after end of treatment (approximately 1 year)

Secondary outcomes (1)

  1. The anti-tumor efficacy as measured by Objective Response Rate (ORR).

    Objective response rate (ORR) at 4 months, defined as the proportion of patients with a documented PR or CR according to the RECIST version 1.1 and irRECIST; as a total cohort and BRCA1/2 carriers versus wildtype.

    Measured: 4 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2019
  2. Study start19 Apr 2019
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03964532
Sponsor's protocol ID
STUDY00000023
Status last verified
Sep 2026
First submitted
22 Apr 2019
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Talazoparib and Avelumab in people with Breast Cancer, run by Georgetown University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantification of Grade 3 and 4 toxicities (Adverse Events) (time frame: from the start of study drugs through 30 days after end of treatment (approximately 1 year)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03964532.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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