What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those similar to Talazoparib (a PARP inhibitor), include endocrine therapies and other PARP inhibitors. PARP inhibitors like Talazoparib can cause side effects such as nausea, fatigue, anemia, and increased liver function tests. Endocrine therapies, such as tamoxifen, may result in hot flashes, vaginal discharge, and an increased risk of blood clots. Aromatase inhibitors, another class of endocrine therapy, can lead to bone density loss, fractures, and cardiovascular risks.

What prior FDA approvals exist?

The FDA has approved several PARP inhibitors for the treatment of breast cancer, particularly for patients with BRCA mutations. Talazoparib is one such PARP inhibitor being studied for its effectiveness in treating metastatic breast cancer with BRCA1 or BRCA2 mutations. Other FDA-approved PARP inhibitors for breast cancer include Olaparib, which is approved for germline BRCA-mutated, HER2-negative metastatic breast cancer, and Niraparib, which is also being evaluated for its efficacy in various cancers, including breast cancer. These drugs work by inhibiting the PARP enzyme, thereby preventing cancer cells from repairing their DNA, leading to cell death.

What other types of research exist?

Promising alternatives to Talazoparib for breast cancer patients include Olaparib and Rucaparib, both of which are PARP inhibitors that have shown efficacy in treating BRCA-mutated breast cancer. Additionally, Pembrolizumab, an immune checkpoint inhibitor, has shown promise in patients with high tumor mutational burden. These treatments offer novel mechanisms of action and have been evaluated in clinical trials for their effectiveness in breast cancer.

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PARP Inhibitor

Talazoparib for Breast Cancer

Phase 2

Recruiting

Led By Neelima Vidula, 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

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

Triple negative breast cancer with disease progression on at least one prior chemotherapy regimen in the metastatic setting

Must not have

Patients should not be on strong P-glycoprotein inhibitors

Had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of treatment until treatment discontinuation, up to approximately 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing talazoparib, a drug that may help treat breast cancer that has spread and has specific genetic mutations (BRCA 1 or BRCA 2). Talazoparib works by stopping proteins that repair DNA, making it harder for cancer cells to survive. The goal is to see if this drug can reduce tumor size and slow down cancer growth in these patients. Talazoparib is a new treatment recently approved for use in patients with metastatic breast cancer with germline BRCA mutations.

Who is the study for?

This trial is for adults with metastatic breast cancer that has a specific BRCA mutation detected in tumor DNA, not inherited. Participants must have progressed after prior treatments or be unsuitable for them, and should not be on certain drugs or have untreated brain metastases. They need functioning organs and controlled previous cancers, agree to contraception if applicable, and cannot be pregnant.

What is being tested?

The trial tests Talazoparib's effectiveness against metastatic breast cancer with somatic BRCA mutations. It examines how well patients respond to this PARP inhibitor when they've had limited or no success with other therapies including platinum-based chemotherapy.

What are the potential side effects?

Talazoparib may cause blood cell count changes leading to anemia or infection risk increase, nausea, fatigue, hair loss (alopecia), digestive issues like diarrhea or constipation, headache, coughing and shortness of breath.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer does not have a harmful BRCA 1 or 2 mutation.

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My triple negative breast cancer has worsened after at least one chemotherapy treatment.

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My cancer is hormone receptor positive, HER2 negative, and has worsened despite endocrine therapy.

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I am using birth control, am surgically sterile, or not having heterosexual sex for the study and 7 months after.

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I do not have a BRCA 1 or 2 gene mutation.

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My metastatic breast cancer has BRCA 1 or 2 mutations.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking strong P-glycoprotein inhibitors.

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I haven't had cancer treatment or recovered from its side effects in the last 2 weeks.

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I have an active Hepatitis B or C infection.

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I am not currently on any cancer treatments.

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I do not have a BRCA 1 or 2 gene mutation.

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I have been diagnosed with HIV.

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I have untreated brain metastases or cancer in the lining of my brain.

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I have never been treated with a PARP inhibitor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of treatment until treatment discontinuation, up to approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of treatment until treatment discontinuation, up to approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of treatment until treatment discontinuation, up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Median Progression Free Survival

Secondary study objectives

Number of Participants with Treatment-related Serious Adverse Events

Objective Response Rate

Side effects data

From 2018 Phase 1 & 2 trial • 40 Patients • NCT02116777

100%

Fatigue

100%

Headache

67%

Platelet count decreased

67%

Hyperglycemia

67%

Anemia

67%

Back pain

33%

Investigations - Other, BUN DECREASED

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%

Alkaline phosphatase increased

33%

Neuralgia

33%

Skin and subcutaneous tissue disorders - Other, LEFT LOWER LEG ERYTHEMA

33%

Anorexia

100%

80%

60%

40%

20%

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

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: TalazoparibExperimental Treatment1 Intervention

-Talazoparib will be provided as capsules for oral administration daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Talazoparib

2021

Completed Phase 2

~2810

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for breast cancer include hormone therapy, chemotherapy, targeted therapy, and PARP inhibitors like Talazoparib. PARP inhibitors work by blocking the PARP enzyme, which helps repair DNA damage in cells. In cancer cells with BRCA1 or BRCA2 mutations, this blockage leads to the accumulation of DNA damage, causing cell death. This mechanism is particularly important for breast cancer patients with these genetic mutations, as it offers a targeted approach that can improve treatment efficacy and outcomes.

Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.