Trial Outcomes & Findings for Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer (NCT NCT00347438)

Results Overview

Overall clinical response rate (OCR) was defined as a proportion of patients with a best response of Complete Clinical Response (CCR) or Partial Clinical Response (PCR). CCR was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease. PCR was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

After the first three cycles of therapy, an average of 9 weeks

Results posted on

2015-12-14

Participant Flow

Participant milestones

Participant milestones
Measure	Capecitabine Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m\^2 twice daily.
Overall Study STARTED	18
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Capecitabine Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m\^2 twice daily.
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1

Baseline Characteristics

Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capecitabine n=18 Participants Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m\^2 twice daily.
Age, Continuous	50.1 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: After the first three cycles of therapy, an average of 9 weeks

Population: This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.

Overall clinical response rate (OCR) was defined as a proportion of patients with a best response of Complete Clinical Response (CCR) or Partial Clinical Response (PCR). CCR was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease. PCR was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.

Outcome measures

Outcome measures
Measure	Capecitabine n=16 Participants Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m\^2 twice daily.
Overall Clinical Response Rate (OCR)	31.3 percentage of participants

PRIMARY outcome

Timeframe: After the first three cycles of therapy, an average of 9 weeks

Population: This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.

Partial Clinical Response (PR) was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.

Outcome measures

Outcome measures
Measure	Capecitabine n=16 Participants Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m\^2 twice daily.
Partial Clinical Response Rate (PR)	5 participants

PRIMARY outcome

Timeframe: After the first three cycles of therapy, an average of 9 weeks

Population: This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.

Complete Clinical Response (CCR) was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease.

Outcome measures

Outcome measures
Measure	Capecitabine n=16 Participants Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m\^2 twice daily.
Complete Clinical Response Rate (CCR)	0 percentage of participants

PRIMARY outcome

Timeframe: After the first three cycles of therapy, an average of 9 weeks

Population: This study was terminated early as a result of slow accrual. Thus, outcome measures were reported only for 16 patients who completed the first three cycles of capecitabine chemotherapy.

Complete Pathologic Response rate (cPR) was defined as the absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery.

Outcome measures

Outcome measures
Measure	Capecitabine n=16 Participants Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m\^2 twice daily.
Complete Pathologic Response Rate (cPR)	0 percentage of participants

Adverse Events

Capecitabine

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Capecitabine n=16 participants at risk Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m\^2 twice daily.
Gastrointestinal disorders Diarrhea	18.8% 3/16
Skin and subcutaneous tissue disorders Skin rash	6.2% 1/16
Skin and subcutaneous tissue disorders Hand and foot syndrome	75.0% 12/16
General disorders Fatigue	6.2% 1/16
Nervous system disorders Dizziness	6.2% 1/16
Metabolism and nutrition disorders Anorexia	6.2% 1/16
Gastrointestinal disorders Nausea	6.2% 1/16
Respiratory, thoracic and mediastinal disorders Sore throat	6.2% 1/16

Additional Information

Dr. Funmi Olopade

University of Chicago Medical Center

Phone: 773-702-1632

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place