Trial Outcomes & Findings for Multicenter Phase II Study of Apatinib in Patients With Advanced Breast Cancer(CABC006) (NCT NCT02878057)

Last Updated: 2021-01-27

Results Overview

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

evaluation per 2 cycles (8 weeks), up to 6 months;From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Results posted on

2021-01-27

Participant Flow

finished recritment

Participant milestones

Participant milestones
Measure	Advanced Breast Cancer Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis; Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive) Apatinib: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)
Overall Study STARTED	30
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multicenter Phase II Study of Apatinib in Patients With Advanced Breast Cancer(CABC006)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Advanced Breast Cancer n=30 Participants Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis; Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, Apatinib: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)
Age, Continuous	49.5 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	30 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	0 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
Lines of Chemotherapy Prior to Enrollment 1	4 Participants n=5 Participants
Lines of Chemotherapy Prior to Enrollment 2	10 Participants n=5 Participants
Lines of Chemotherapy Prior to Enrollment ≥3	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: evaluation per 2 cycles (8 weeks), up to 6 months;From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Outcome measures

Outcome measures
Measure	Advanced Breast Cancer n=26 Participants Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis; Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive) Apatinib: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)
Progression-free Survival	4.9 months Interval 2.1 to 8.3

PRIMARY outcome

Timeframe: evaluation per 2 cycles (8 weeks), up to 55 months

Population: Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis;

survival from first dose to death or last follow up

Outcome measures

Outcome measures
Measure	Advanced Breast Cancer n=26 Participants Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis; Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive) Apatinib: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)
Overall Survival	18 months Interval 3.0 to 55.0

SECONDARY outcome

Timeframe: evaluation per 2 cycles (8 weeks), up to 55 months

Population: Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis;

Outcome measures

Outcome measures
Measure	Advanced Breast Cancer n=26 Participants Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis; Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive) Apatinib: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)
Objective Response Rate	11 Participants

SECONDARY outcome

Timeframe: evaluation per 2 cycles (8 weeks), up to 55 months

Population: Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis;

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression Disease (PD), \>=20% increase in the sum of the longest diameter of target lesions or appearance of new lesions; Stable Disease (SD), between PR and PD. Disease control rate (DCR) = CR + PR + SD.

Outcome measures

Outcome measures
Measure	Advanced Breast Cancer n=26 Participants Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis; Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive) Apatinib: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)
Disease Control Rate	20 Participants

SECONDARY outcome

Timeframe: evaluation per 2 cycles (8 weeks), up to 55 months

Population: Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis

all kind of adverse events, including hypertension, proteinuria, nausea, fatigue, and bilirubin increase.

Outcome measures

Outcome measures
Measure	Advanced Breast Cancer n=30 Participants Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis; Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive) Apatinib: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)
Number of Participants With Adverse Events	15 Participants

Adverse Events

Advanced Breast Cancer

Serious events: 12 serious events

Other events: 1 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Advanced Breast Cancer n=30 participants at risk Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis; Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive) Apatinib: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)
Renal and urinary disorders proteinuria	20.0% 6/30 • through study completion, an median of 18 months The apatinib dose given was reduced from 500mg to 250mg for 60% of patients because of side effects.
Cardiac disorders Hypertension	6.7% 2/30 • through study completion, an median of 18 months The apatinib dose given was reduced from 500mg to 250mg for 60% of patients because of side effects.
General disorders Fatigue	3.3% 1/30 • through study completion, an median of 18 months The apatinib dose given was reduced from 500mg to 250mg for 60% of patients because of side effects.
Hepatobiliary disorders Bilirubin increased	6.7% 2/30 • through study completion, an median of 18 months The apatinib dose given was reduced from 500mg to 250mg for 60% of patients because of side effects.
Hepatobiliary disorders Transaminase increased	3.3% 1/30 • through study completion, an median of 18 months The apatinib dose given was reduced from 500mg to 250mg for 60% of patients because of side effects.

Other adverse events

Other adverse events
Measure	Advanced Breast Cancer n=30 participants at risk Patients With HER-2 Negative Advanced Breast Cancer With Chest Wall Metastasis; Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive) Apatinib: Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)
General disorders Infection	3.3% 1/30 • through study completion, an median of 18 months The apatinib dose given was reduced from 500mg to 250mg for 60% of patients because of side effects.

Additional Information

Dr. Huiping Li

Department of Breast Oncology, Peking University Cancer Hospital and Institute

Phone: 86-10-88196739

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place