Trial Outcomes & Findings for Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast (NCT NCT00496808)

Results Overview

Percent Change in Proliferation as measured by Ki-67 (% nuclei stained). Comparison of proliferation rates of Her-2/neu overexpressing cells before and after treatment with Herceptin per Participant where absolute change defined as difference of increase/decrease. Proliferation rate evaluated by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

69 participants

Primary outcome timeframe

Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks

Results posted on

2020-09-23

Participant Flow

Recruitment Period: March 2005 - November 2010. All recruitment was at UT MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Herceptin 8 mg/kg intravenously (IV) Over 90 Minutes
Overall Study STARTED	69
Overall Study COMPLETED	69
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Herceptin n=69 Participants 8 mg/kg intravenously (IV) Over 90 Minutes
Age, Continuous	53 years n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants

PRIMARY outcome

Timeframe: Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks

Percent Change in Proliferation as measured by Ki-67 (% nuclei stained). Comparison of proliferation rates of Her-2/neu overexpressing cells before and after treatment with Herceptin per Participant where absolute change defined as difference of increase/decrease. Proliferation rate evaluated by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks

Population: Twelve evaluable patients were required to characterize the change in proliferation rate after treatment with a single dose of Herceptin (trastuzumab). Those participants who completed Herceptin administration, surgery, and post surgery bio-markers testing were evaluable.

Proliferation rate and apoptotic index measured on core biopsy specimen and resection specimen from each participants. To compare Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and CD4+ T-cell response in each participant observed at pre- and post-treatment times, paired analysis was performed using Student's t-test. Nonparametric Wilcoxon rank sum test was used to compare data between groups.

Outcome measures

Outcome measures
Measure	Herceptin n=12 Participants 8 mg/kg intravenously (IV) Over 90 Minutes
Number of Participants Achieving Documented Change in Proliferation	12 Participants

SECONDARY outcome

Timeframe: Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks

Population: Analysis was per protocol. Twelve evaluable patients were required to characterize the change in proliferation rate after treatment with a single dose of Herceptin (trastuzumab). Those participants who completed Herceptin administration, surgery, and post surgery bio-markers testing were evaluable.

Mean percent of Ki-67 (% nuclei stained) at immunohistochemical staining performed for biomarkers. Tissue sections from diagnostic core biopsy tissue that contains DCIS before treatment and from corresponding tissues that contain DCIS from the surgical resection obtained after a single dose of Herceptin.

Outcome measures

Outcome measures
Measure	Herceptin n=12 Participants 8 mg/kg intravenously (IV) Over 90 Minutes
Mean Percent of Ki-67	44.29 Percentage of Ki-67 Standard Deviation 3.42

Adverse Events

Herceptin

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Herceptin n=69 participants at risk 8 mg/kg intravenously (IV) Over 90 Minutes
General disorders Infusion reaction	2.9% 2/69 • Number of events 2 • 3 years and 2 months
Nervous system disorders Neuropathy: Sensory	1.4% 1/69 • Number of events 1 • 3 years and 2 months

Other adverse events

Adverse event data not reported

Additional Information

Raphael E Pollock,PHD/Professor Emeritus, Surgical Oncology

UT MD Anderson Cancer Center

Phone: (713) 792-6928

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place