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

August 14, 2019 updated by: Instituto Nacional de Cancer, Brazil

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20560120
        • Recruiting
        • Hospital do Cancer III
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Megestrol acetate
Megestrol acetate 160 mg PO daily until disease progression or unacceptable toxicity Tumor biopsy and blood collection before treatment initiation and at the time of disease progression.
Drug: Megestrol Acetate 160Mg Tablet
Megestrol acetate 160 mg PO daily
Other Names:
  • MA
Active Comparator: Anastrozole
Anastrozole 1 mg PO daily until disease progression or unacceptable toxicity Tumor biopsy and blood collection before treatment initiation and at the time of disease progression.
Drug: Anastrozole 1Mg Tablet
Anastrozole 1 mg PO daily OR
Other Names:
  • Anastrozole
Active Comparator: Letrozole
Letrozole 2.5 mg PO daily until disease progression or unacceptable toxicity Tumor biopsy and blood collection before treatment initiation and at the time of disease progression.
Drug: Letrozole 2.5Mg Tablet
Letrozole 2.5 mg PO daily OR
Other Names:
  • Letrozole
Active Comparator: Exemestane
Exemestane 25 mg PO daily until disease progression or unacceptable toxicity Tumor biopsy and blood collection before treatment initiation and at the time of disease progression.
Drug: Exemestane 25 MG
Exemestane 25 mg PO daily
Other Names:
  • Exemestane
Active Comparator: Tamoxifen
Tamoxifen 20 mg PO daily until disease progression or unacceptable toxicity Tumor biopsy and blood collection before treatment initiation and at the time of disease progression.
Drug: Tamoxifen 20Mg Tablet
Tamoxifen 20 mg PO daily
Other Names:
  • Tamoxifen
Active Comparator: Fulvestrant
Fulvestrant 500 mg intramuscularly (IM) d1, d14, d28 and q28 days until disease progression or unacceptable toxicity Tumor biopsy and blood collection before treatment initiation and at the time of disease progression.
Drug: Fulvestrant 50Mg Solution for Injection
Fulvestrant 500 mg IM d1, d14, d28 and q28 days
Other Names:
  • Fulvestrant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: From date of randomization until disease progression or death due to any cause, assessed up to 18 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of randomization until death, assessed up to 18 months
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
Clinical benefit
Time Frame: Partial response and stable disease for more than 24 weeks, assessed up to 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancer, Brazil

Collaborators

Cancer Research UK Cambridge Institute

Investigators

  • Study Chair: José Bines, MD, PhD, Instituto Nacional de Cancer, Brazil
  • Study Chair: Jason Carroll, PhD, Cancer Research UK Cambridge Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2017

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

January 4, 2017

First Submitted That Met QC Criteria

January 16, 2017

First Posted (Estimate)

January 19, 2017

Study Record Updates

Last Update Posted (Actual)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 64/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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