Factors Influencing Tamoxifen Adherence in Women With Breast Cancer Receiving Tamoxifen in Botswana.

NCT06660030 | Terminated

• 1 other identifier: 855696
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Botswana is an ideal location to investigate tamoxifen adherence for numerous reasons. First, in contrast to many other countries in SSA, tamoxifen is affordable and widely available to women with ER+ breast cancer in Botswana. There is also a sufficiently high prevalence of WLW HIV and breast cancer in Botswana to provide adequate power for the proposed study. Lastly, there is a well-developed medical and scientific infrastructure, both from the clinical and laboratory perspective, to allow for successful completion of this proposed study

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  Reduced tamoxifen adherence, measured as reduced intake of pills number will be seen in women with reduced quality of EORTC QLQ( Cancer core quality of life questionnare acronym Q-C30 life scores, increased medication side effects, and/or increased barriers to medical care. Women living with (WLW) HIV taking tamoxifen will be less adherent to tamoxifen therapy due to the higher likelihood of medication side effects

  12 months

Secondary Outcomes (1)

• Secondary outcome

  12 months

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women with breast cancer
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will include females with ER+ breast cancer who are \>18 years of age. The study population will include both women living with and without HIV. Patients offered questionnaires and blood draws will only include women treated as outpatients and be of sufficient mental capacity to personally consent to the study.

You may qualify if:

• All women over the age of 18, taking (or have taken) tamoxifen for treatment of ER+ breast cancer and being HIV positive
• All women over the age of 18, taking (or have taken) tamoxifen for treatment of ER+ breast cancer and being HIV negative

You may not qualify if:

• Males
• Women with ER negative breast cancer
• Women under 18 years of age at time of study administration.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Princess Marina Hospital

Gaborone, 267, Botswana

Location

Biospecimen

Retention: SAMPLES WITH DNA

Approximately 4 ml of blood will be drawn from consenting patients following questionnaire administration in EDTA ( this is an anticoagulant to collect whole blood in tubes ) tubes. Blood will be immediately centrifuged after collection, and plasma and buffy coat stored for drug/metabolites detection/quantification, and DNA analysis, respectively. DNA extraction technique:( this is a DNA extraction kit) QIAamp DNA Mini Kits (Qiagen, Hilden, Germany) kits will be used for whole genomic DNA, according to the manufacture's instructions.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: March 1, 2024
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

BO (1)