Trial Outcomes & Findings for BrUOG 390: Neoadjuvant Treatment With Talazoparib (NCT NCT04598321)

NCT ID: NCT04598321

Last Updated: 2023-10-12

Results Overview

Define the proportion of volunteers completing the planned 9 weeks of treatment without disease progression.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 1 participants
• Primary outcome timeframe: First 9 weeks of treatment
• Results posted on: 2023-10-12

Participant Flow

Participant milestones

Measure	Planned Therapy Talazoparib monotherapy as 1 mg capsule orally on a daily basis for three cycles, defined as a 21-day period, prior to surgery. Volunteers will continue treatment to complete three cycles, unless disease progression or unacceptable toxicity occurs.Volunteers who complete neoadjuvant treatment with talazoparib should undergo surgical cytoreduction within three weeks of their last dose of talazoparib. All volunteers should then undergo standard of care adjuvant therapy using carboplatin and paclitaxel. For volunteers, who agree to continue talazoparib as maintenance therapy, treatment should begin three weeks (+/- 2 weeks) from the end of adjuvant chemotherapy or after cytoreductive surgery alone. Talazoparib Oral Capsule: An orally available PARP inhibitor for the treatment of advanced breast cancer with germline BRCA mutations.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BrUOG 390: Neoadjuvant Treatment With Talazoparib

Baseline characteristics by cohort

Measure	Planned Therapy n=1 Participants Talazoparib monotherapy as 1 mg capsule orally on a daily basis for three cycles, defined as a 21-day period, prior to surgery. Volunteers will continue treatment to complete three cycles, unless disease progression or unacceptable toxicity occurs.Volunteers who complete neoadjuvant treatment with talazoparib should undergo surgical cytoreduction within three weeks of their last dose of talazoparib. All volunteers should then undergo standard of care adjuvant therapy using carboplatin and paclitaxel. For volunteers, who agree to continue talazoparib as maintenance therapy, treatment should begin three weeks (+/- 2 weeks) from the end of adjuvant chemotherapy or after cytoreductive surgery alone. Talazoparib Oral Capsule: An orally available PARP inhibitor for the treatment of advanced breast cancer with germline BRCA mutations.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: First 9 weeks of treatment

Define the proportion of volunteers completing the planned 9 weeks of treatment without disease progression.

Outcome measures

Measure

Planned Therapy n=1 Participants Talazoparib monotherapy as 1 mg capsule orally on a daily basis for three cycles, defined as a 21-day period, prior to surgery. Volunteers will continue treatment to complete three cycles, unless disease progression or unacceptable toxicity occurs.Volunteers who complete neoadjuvant treatment with talazoparib should undergo surgical cytoreduction within three weeks of their last dose of talazoparib. All volunteers should then undergo standard of care adjuvant therapy using carboplatin and paclitaxel. For volunteers, who agree to continue talazoparib as maintenance therapy, treatment should begin three weeks (+/- 2 weeks) from the end of adjuvant chemotherapy or after cytoreductive surgery alone. Talazoparib Oral Capsule: An orally available PARP inhibitor for the treatment of advanced breast cancer with germline BRCA mutations.

Determine the Preliminary Effectiveness of Talazorparib

1 Participants

SECONDARY outcome

Timeframe: First 2 years of study.

Define whether 30 volunteers can successfully be enrolled within 2 years within participating institutions.

Outcome measures

Measure

Planned Therapy n=1 Participants Talazoparib monotherapy as 1 mg capsule orally on a daily basis for three cycles, defined as a 21-day period, prior to surgery. Volunteers will continue treatment to complete three cycles, unless disease progression or unacceptable toxicity occurs.Volunteers who complete neoadjuvant treatment with talazoparib should undergo surgical cytoreduction within three weeks of their last dose of talazoparib. All volunteers should then undergo standard of care adjuvant therapy using carboplatin and paclitaxel. For volunteers, who agree to continue talazoparib as maintenance therapy, treatment should begin three weeks (+/- 2 weeks) from the end of adjuvant chemotherapy or after cytoreductive surgery alone. Talazoparib Oral Capsule: An orally available PARP inhibitor for the treatment of advanced breast cancer with germline BRCA mutations.

Feasibility of the Trial Design.

1 Participants

Adverse Events

Planned Therapy

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure

Planned Therapy n=1 participants at risk Talazoparib monotherapy as 1 mg capsule orally on a daily basis for three cycles, defined as a 21-day period, prior to surgery. Volunteers will continue treatment to complete three cycles, unless disease progression or unacceptable toxicity occurs.Volunteers who complete neoadjuvant treatment with talazoparib should undergo surgical cytoreduction within three weeks of their last dose of talazoparib. All volunteers should then undergo standard of care adjuvant therapy using carboplatin and paclitaxel. For volunteers, who agree to continue talazoparib as maintenance therapy, treatment should begin three weeks (+/- 2 weeks) from the end of adjuvant chemotherapy or after cytoreductive surgery alone. Talazoparib Oral Capsule: An orally available PARP inhibitor for the treatment of advanced breast cancer with germline BRCA mutations.

Gastrointestinal disorders Small intestinal obstruction

100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.

Other adverse events

Measure	Planned Therapy n=1 participants at risk Talazoparib monotherapy as 1 mg capsule orally on a daily basis for three cycles, defined as a 21-day period, prior to surgery. Volunteers will continue treatment to complete three cycles, unless disease progression or unacceptable toxicity occurs.Volunteers who complete neoadjuvant treatment with talazoparib should undergo surgical cytoreduction within three weeks of their last dose of talazoparib. All volunteers should then undergo standard of care adjuvant therapy using carboplatin and paclitaxel. For volunteers, who agree to continue talazoparib as maintenance therapy, treatment should begin three weeks (+/- 2 weeks) from the end of adjuvant chemotherapy or after cytoreductive surgery alone. Talazoparib Oral Capsule: An orally available PARP inhibitor for the treatment of advanced breast cancer with germline BRCA mutations.
Blood and lymphatic system disorders Anemia	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Endocrine disorders Endocrine disorders, other	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Gastrointestinal disorders Abdominal pain	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Gastrointestinal disorders Ascites	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Gastrointestinal disorders Gastritis	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Gastrointestinal disorders Ileal obstruction	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Gastrointestinal disorders Nausea	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Gastrointestinal disorders Vomiting	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
General disorders Edema limbs	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
General disorders Fatigue	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
General disorders Fever	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
General disorders Non-cardiac chest pain	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Infections and infestations Upper respiratory infection	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Investigations Lymphocyte count decreased	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Investigations Weight loss	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Investigations White blood cell decreased	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Metabolism and nutrition disorders Dehydration	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Metabolism and nutrition disorders Hyperglycemia	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Metabolism and nutrition disorders Hypocalcemia	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Musculoskeletal and connective tissue disorders Arthralgia	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Nervous system disorders Dysgeusia	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Nervous system disorders Somnolence	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Respiratory, thoracic and mediastinal disorders Cough	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.
Respiratory, thoracic and mediastinal disorders Wheezing	100.0% 1/1 • From the time a signed and dated ICF was obtained until 30 days after the last treatment, approximately 8 months.

Additional Information

Assistant Director

Brown University Oncology Research Group (BrUOG)

Phone: 401-863-3000

Email: BrUOG@brown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place