Talazoparib in Advanced Breast Cancer Patients With Homologous Recombinant Deficiency: A Phase II Clinical and Exploratory Biomarker Study of Talazoparib

Who is this study for? Patients with advanced breast cancer with homologous recombinant deficiency
What treatments are being studied? Talazoparib
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Talazoparib has shown clinical efficacy in breast cancer patients with germline BRCA1 or BRCA2 mutations. Beyond BRCA1 and BRCA2 mutations, it is plausible that talazoparib may have activity in patients with homologous recombination defects (HRD).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 19
Healthy Volunteers: f
View:

• Adults ≥19 years old.

• Pathologically documented breast cancer that is unresectable or metastatic

• Tumor with homologous recombination deficiency (HRD) defined by

‣ Germline or Somatic BRCA1/2 mutation

⁃ Homologous recombination repair (HRR) genes mutation

⁃ HRD detected through RAD51 foci formation functional assay

⁃ HRR genes: ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, and RAD54L

• Previously treated with a taxane, unless this treatment was contraindicated (whether in recurrent/metastatic setting or in neoadjuvant/adjuvant setting).

• Previous treatment with platinum therapy in the advanced or metastatic setting is permitted, provided the patient did not have a progression during the platinum treatment. If the patient was treated with neoadjuvant or adjuvant platinum therapy, at least 6 months of disease-free interval is required after the last dose.

• Documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy).

• \- If the patients had relapsed within 6 months after adjuvant therapy, this will be counted as a systemic chemotherapy for advanced or metastatic disease.

• At least 3 weeks has passed since last chemotherapy treatment

• At least 2 weeks has passed since last hormone therapy or radiation therapy (including palliative radiation).

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1

⁃ At least one measurable lesion that can be accurately assessed at baseline by computed tomography (CT) (magnetic resonance imaging \[MRI\] where CT is not feasible) and is suitable for repeated assessment as per RECIST v.1.1.

⁃ Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7.0 months after the last dose of study treatment.

⁃ \- This study recommend Copper T intrauterine device as a highly effective methods of contraception (\<1% failure rate)

⁃ Adequate normal organ and marrow function measured within 28 days prior to administration of study treatment

∙ Hemoglobin ≥9.0 g/dL

‣ Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

‣ Platelet count ≥ 75 x 109/L

‣ Serum bilirubin ≤ 2.0mg/dL \[This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\]

‣ AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN

‣ Adequate renal function: Serum creatinine ≤1.5mg/dL or estimated creatinine clearance \>60 mL/min

⁃ Negative urine pregnancy test within 7 days prior to registration in premenopausal patients.

⁃ Ability to understand and comply with protocol during study period

⁃ Patients should sign a written informed consent before study entry

Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Seock-Ah Im, MD, PhD
moisa@snu.ac.kr
82-2-2072-0850
Backup
Yuri Park, RN
sesame1025@gmail.com
82-2-3668-7088
Time Frame
Start Date: 2021-05-25
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 70
Treatments
Experimental: Talazoparib
; Talazoparib should be taken orally once daily (ie, continuous daily dosing) at approximately the same time each day (preferably in the morning). Daily dosing of talazoparib can be interrupted for recovery from toxicity for up to 28 days. For interruptions longer than 28 days, treatment at the same or a reduced dose can be considered based on the discretion of the treating physician.
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov