Trial Outcomes & Findings for Neoadjuvant Tamoxifen in Locally Advanced Breast Cancer in a Low/Middle Income Country (NCT NCT02806544)

Results Overview

Feasibility is defined as the ability to recruit the stated number of patients and fifty percent of participants completing the trial. Completing the trial is defined as reaching surgery if they are a responder to tamoxifen or obtaining the six week biopsy specimen if they are a non-responder.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

4-6 months

Results posted on

2017-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	Tamoxifen Tamoxifen 20mg by mouth daily Tamoxifen: Tamoxifen 20mg by mouth daily
Overall Study STARTED	35
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neoadjuvant Tamoxifen in Locally Advanced Breast Cancer in a Low/Middle Income Country

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tamoxifen n=35 Participants Tamoxifen 20mg by mouth daily Tamoxifen: Tamoxifen 20mg by mouth daily
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	59.1 years n=5 Participants
Gender Female	35 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants
Region of Enrollment Guatemala	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 4-6 months

Population: The number of patients analyzed was the accrual goal for number of participants and the outcome measure was the actual number of participants accrued. The outcome measure time frame is the maximum time each participant would be on study.

Feasibility is defined as the ability to recruit the stated number of patients and fifty percent of participants completing the trial. Completing the trial is defined as reaching surgery if they are a responder to tamoxifen or obtaining the six week biopsy specimen if they are a non-responder.

Outcome measures

Outcome measures
Measure	Tamoxifen n=50 Participants Tamoxifen 20mg by mouth daily Tamoxifen: Tamoxifen 20mg by mouth daily
Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility	35 participants

SECONDARY outcome

Timeframe: 4-6 months

Rate of definitive surgery after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be "responders" to neoadjuvant tamoxifen (Ki67 \< or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy)

Outcome measures

Outcome measures
Measure	Tamoxifen n=35 Participants Tamoxifen 20mg by mouth daily Tamoxifen: Tamoxifen 20mg by mouth daily
Number of Participants With Definitive Surgery in Responders to Neoadjuvant Tamoxifen	13 participants

SECONDARY outcome

Timeframe: 4-6 weeks

Population: 32 of the 35 patients underwent an on-treatment biopsy; 3 patients did not follow-up and were not included in the number of participants analyzed for this measure.

Result is the number of participants who had Ki67 suppression (\< or = 10%) after 4-6 weeks of neoadjuvant tamoxifen out of patients who underwent an on-treatment biopsy.

Outcome measures

Outcome measures
Measure	Tamoxifen n=32 Participants Tamoxifen 20mg by mouth daily Tamoxifen: Tamoxifen 20mg by mouth daily
Ki67 Suppression Rate at 4-6 Weeks in Patients Who Underwent an On-treatment Biopsy	15 participants

SECONDARY outcome

Timeframe: 4-6 months

Population: This Outcome Measure was only assessed among patients undergoing surgery and is a unique outcome measure.

Clinical response rate was assessed by palpation after 4 months of tamoxifen. Complete response was defined as no palpable primary tumor on clinical examination and lymph nodes \< 10 mm. Partial response was defined as at least 30% decrease in the sum of the diameters compared to baseline sum of diameters. The overall clinical response was the sum of the complete clinical response and partial clinical response.

Outcome measures

Outcome measures
Measure	Tamoxifen n=13 Participants Tamoxifen 20mg by mouth daily Tamoxifen: Tamoxifen 20mg by mouth daily
Overall Clinical Response Rate	13 participants

SECONDARY outcome

Timeframe: 4-6 months

Population: This Outcome Measure was only assessed among patients who had undergone surgery.

Pathologic complete response was defined as no residual tumor at the primary site or the axillary lymph nodes at the time of surgery.

Outcome measures

Outcome measures
Measure	Tamoxifen n=13 Participants Tamoxifen 20mg by mouth daily Tamoxifen: Tamoxifen 20mg by mouth daily
Pathologic Complete Response	1 participants

SECONDARY outcome

Timeframe: 4-6 months

Population: This outcome measure was analyzed in patients who were treated with 4 months of neoadjuvant tamoxifen

The rate of breast conservation surgery (as opposed to mastectomy) after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be "responders" to neoadjuvant tamoxifen (Ki67 \< or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy).

Outcome measures

Outcome measures
Measure	Tamoxifen n=15 Participants Tamoxifen 20mg by mouth daily Tamoxifen: Tamoxifen 20mg by mouth daily
Breast Conserving Therapy	0 participants

Adverse Events

Tamoxifen

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

Laila Agrawal

Vanderbilt University

Phone: 615-322-4967

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place