Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

Hormones

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Laila Agrawal, MD

This study evaluates the feasibility and efficacy of neoadjuvant tamoxifen for patients with locally advanced hormone receptor positive breast cancer in a low/middle income country.

This is a single arm feasibility study of neoadjuvant tamoxifen for locally advanced hormone receptor positive breast cancer in a low-resource setting in a middle-income country (Guatemala). Patients will be treated with tamoxifen for four to six weeks, then have an on-treatment biopsy to assess Ki-67. If Ki-67 is less than or equal to 10%, the patient will continue on tamoxifen for a total of 4 months; if Ki-67 is greater than 10% or there is clinical progression, patients will be taken off study. The study will evaluate the proportion of patients treated with four months of tamoxifen who undergo definitive surgery and the clinical and pathologic response rates.

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

Neoadjuvant Endocrine Therapy in Locally Advanced Hormone Receptor Positive Breast Cancer in a Low-Resource, Middle-Income Setting (Guatemala)

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.

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)

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.

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.

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

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).

Washington University School of Medicine

Instituto National de Cancerologia, Guatemala

Vanderbilt University

Clinical Fellow

Tamoxifen 20mg by mouth daily

Tamoxifen: Tamoxifen 20mg by mouth daily

Age, Categorical

Age, Continuous

Gender

Guatemala

Region of Enrollment

Laila Agrawal

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.

Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility

Number of Participants With Definitive Surgery in Responders to Neoadjuvant Tamoxifen

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.

Ki67 Suppression Rate at 4-6 Weeks in Patients Who Underwent an On-treatment Biopsy

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

Overall Clinical Response Rate

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

Pathologic Complete Response

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant Tamoxifen in Locally Advanced Breast Cancer in a Low/Middle Income Country	NCT02806544	Breast Cancer Breast Neoplasm...	Tamoxifen	18 Years -	Vanderbilt University
Neoadjuvant Tamoxifen in Locally Advanced Breast Cancer in a Low/Middle Income Country	NCT02806544	Breast Cancer Breast Neoplasm...	Tamoxifen	18 Years -	Vanderbilt University

Spots Global Cancer Trial Database for low and middle income country