Trial Outcomes & Findings for Dose Dense Carboplatin, Taxotere and Herceptin As Primary Systemic Therapy in Breast Cancer (NCT NCT00232479)

Results Overview

pCR is defined as the absence of invasive tumor from the surgical specimen of breast and axilla which is obtained after the chemotherapy regimen has been delivered.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

determined at the time of surgery which is approximately 16 weeks from the beginning of treatment

Results posted on

2012-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 study group receives taxotere, herceptin and carboplatin in dose dense fashion
Overall Study STARTED	44
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose Dense Carboplatin, Taxotere and Herceptin As Primary Systemic Therapy in Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=44 Participants treat with taxotere, herceptin, carboplatin in dose dense fashion
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age Continuous	51 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants

PRIMARY outcome

Timeframe: determined at the time of surgery which is approximately 16 weeks from the beginning of treatment

Population: 48 patients signed consent but only 44 were evaluable. To be evaluable the patient must have received at least one dose of chemo and then had surgery. Two patients withdrew consent before treatment and two patients did not have surgery. So 44 are evaluable for the primary endpoint

pCR is defined as the absence of invasive tumor from the surgical specimen of breast and axilla which is obtained after the chemotherapy regimen has been delivered.

Outcome measures

Outcome measures
Measure	Group 1 n=44 Participants patients received dose dense herceptin, carboplatin and taxotere
Number of Patients With Pathologic Complete Response (pCR)	19 participants

SECONDARY outcome

Timeframe: from the first dose of chemotherapy until surgery which was approximately 16 weeks.

Population: 48 patients signed an initial informed consent. 2 withdrew consent before treatment. 2 withdrew after starting treatment. Only 44 are evaluable for primary endpoint because 2 did not go for surgery.

the number of patients with grade 4 (severe) toxicities and or hospitalizations were measured to assess safety and tolerability

Outcome measures

Outcome measures
Measure	Group 1 n=44 Participants patients received dose dense herceptin, carboplatin and taxotere
Safety and Tolerability	1 participants

Adverse Events

Group 1

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 n=46 participants at risk patients received herceptin, carboplatin, taxotere in dose dense fashion
Gastrointestinal disorders hospitalization	2.2% 1/46 • Number of events 1 • adverse events were collected for the 16 week pre-operative period while the study was open to accrual over a three year period. toxicity coded and graded using the CTC 2.0

Other adverse events

Adverse event data not reported

Additional Information

Judith Hurley

UMiami

Phone: 305-243-6698

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60