Trial Outcomes & Findings for Neo-adjuvant Therapy With Anastrozole Plus Pazopanib in Stage II and III ER+ Breast Cancer (NCT NCT01394211)

Results Overview

Defined as no evidence of microscopic invasive tumor present. Determined by pathology. Estimated with an exact 95% confidence interval.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Six months from the initiation of neoadjuvant therapy

Results posted on

2018-07-26

Participant Flow

Through physician

Participant milestones

Participant milestones
Measure	Neoadjuvant Enzyme Inhibitor Therapy Patients receive pazopanib hydrochloride\* PO QD and anastrozole PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients then undergo therapeutic conventional surgery. NOTE: \*Pazopanib hydrochloride is stopped 7-14 days before definitive surgery. anastrozole: Given PO pazopanib hydrochloride: Given PO therapeutic conventional surgery: Undergo definitive surgery
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neo-adjuvant Therapy With Anastrozole Plus Pazopanib in Stage II and III ER+ Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neoadjuvant Enzyme Inhibitor Therapy n=2 Participants Patients receive pazopanib hydrochloride\* PO QD and anastrozole PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients then undergo therapeutic conventional surgery. NOTE: \*Pazopanib hydrochloride is stopped 7-14 days before definitive surgery. anastrozole: Given PO pazopanib hydrochloride: Given PO therapeutic conventional surgery: Undergo definitive surgery
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Six months from the initiation of neoadjuvant therapy

Population: Participants withdrew from participation

Defined as no evidence of microscopic invasive tumor present. Determined by pathology. Estimated with an exact 95% confidence interval.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks from the initiation of neoadjuvant therapy

Population: Participants withdrew from participation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Six months from the initiation of neoadjuvant therapy

Population: Participants withdrew from participation

Outcome measures

Outcome data not reported

Adverse Events

Neoadjuvant Enzyme Inhibitor Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Program Coordinator

University of Arizona Cancer Center

Phone: 5206260301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place