A Study Evaluating Megestrol Acetate Modulation in Hormone Receptor Positive Advanced Breast Cancer

Breast Neoplasm Clinical Trial

— MEGA  

Official title:

A Pilot Study Evaluating Megestrol Acetate Modulation in Advanced Breast Cancer With Positive Hormonal Receptor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03024580
• Other study ID #: 64/16
• Status: Recruiting
• Phase: Phase 2
• Start date: March 6, 2017
• Est. completion date: September 2020

Study information

• Verified date: August 2019
• Source: Instituto Nacional de Cancer, Brazil
• Contact: Renata Obadia, RN
• Phone: 552132073810
• Email: robadia[@]inca.gov.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot trial evaluates in vivo megestrol acetate (MA) modulation of steroidal receptors in advanced breast cancer.

Description:

Progesterone receptor (PR) expression has been considered a biomarker of oestrogen receptor-α (ERα) activity. This longstanding relationship has been recently challenged and instead of being merely an ERα-induced gene target, PR may be a critical determinant of ERα activity. The functional significance of this steroid receptor crosstalk is regulation of a gene expression program associated with low tumorigenicity; hence, better disease outcome. Genomic alterations in the PR genomic locus seem to be a relatively common mechanism for reduction of PR expression, which may consequently lead to altered ERα chromatin binding and target gene expression patterns that increase breast tumorigenicity and confers a poor clinical outcome. This ERα-PR crosstalk may be directly influenced by many variables, including the relative receptor levels and the hormonal milieu.

ER-positive advanced breast cancer is a heterogeneous group of diseases with considerable variability in outcome to a range of treatments. Prior response predicts the likelihood of subsequent benefit from another endocrine agent and this should be taken into account in the treatment decision process when assessing whether to prescribe a subsequent endocrine therapy. Despite the enormous progress made regarding the elucidation of breast cancer subgroups and their molecular drivers, most information comes from primary tumors. MA lacks cross-resistance and is active after acquired resistance to potent AI. This pilot trial evaluates in vivo MA modulation of steroidal receptors in advanced breast cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Metastatic breast cancer with ER and/or PR positive (primary tumor)

• Metastatic site amenable to biopsy

Exclusion Criteria:

• Platelet count below 100,000 / mm3

• Renal or hepatic impairment

• Coagulation disorder

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Drug:
• Megestrol Acetate 160Mg Tablet
Megestrol acetate 160 mg PO daily
• Anastrozole 1Mg Tablet
Anastrozole 1 mg PO daily OR
• Letrozole 2.5Mg Tablet
Letrozole 2.5 mg PO daily OR
• Exemestane 25 MG
Exemestane 25 mg PO daily
• Tamoxifen 20Mg Tablet
Tamoxifen 20 mg PO daily
• Fulvestrant 50Mg Solution for Injection
Fulvestrant 500 mg IM d1, d14, d28 and q28 days

Locations

Country	Name	City	State
Brazil	Hospital do Cancer III	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Cancer, Brazil	Cancer Research UK Cambridge Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months	From date of randomization until disease progression or death due to any cause, assessed up to 18 months
Secondary	Overall survival	From date of randomization until the date of death from any cause, assessed up to 18 months	From date of randomization until death, assessed up to 18 months
Secondary	Clinical benefit	Partial response and stable disease for more than 24 weeks, as per RECIST criteria, from date of randomization until the date of first documented progression or date of death, whichever came first, assessed up to 18 months	Partial response and stable disease for more than 24 weeks, assessed up to 18 months