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

NCT03024580 | Unknown Phase 2

• 1 other identifier: 64/16
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Neoplasm

Keywords

Megestrol Acetate; Steroid, Receptors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall survival

  From date of randomization until death, assessed up to 18 months

• Clinical benefit

  Partial response and stable disease for more than 24 weeks, assessed up to 18 months

Study Arms (6)

Megestrol acetate

EXPERIMENTAL

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

Anastrozole

ACTIVE COMPARATOR

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

Letrozole

ACTIVE COMPARATOR

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

Exemestane

ACTIVE COMPARATOR

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

Tamoxifen

ACTIVE COMPARATOR

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

Fulvestrant

ACTIVE COMPARATOR

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

Interventions

Megestrol Acetate 160Mg Tablet DRUG

Megestrol acetate 160 mg PO daily

Also known as: MA

Megestrol acetate

Anastrozole 1Mg Tablet DRUG

Anastrozole 1 mg PO daily OR

Also known as: Anastrozole

Anastrozole

Letrozole 2.5Mg Tablet DRUG

Letrozole 2.5 mg PO daily OR

Also known as: Letrozole

Letrozole

Exemestane 25 MG DRUG

Exemestane 25 mg PO daily

Also known as: Exemestane

Exemestane

Tamoxifen 20Mg Tablet DRUG

Tamoxifen 20 mg PO daily

Also known as: Tamoxifen

Tamoxifen

Fulvestrant 50Mg Solution for Injection DRUG

Fulvestrant 500 mg IM d1, d14, d28 and q28 days

Also known as: Fulvestrant

Fulvestrant

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic breast cancer with ER and/or PR positive (primary tumor)
• Metastatic site amenable to biopsy

You may not qualify if:

• Platelet count below 100,000 / mm3
• Renal or hepatic impairment
• Coagulation disorder

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead
• Cancer Research UK Cambridge Institute: collaborator

Study Sites (1)

Hospital do Cancer III

Rio de Janeiro, 20560120, Brazil

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Megestrol Acetate; Tablets; Anastrozole; Letrozole; exemestane; Tamoxifen; Fulvestrant; Solutions; Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Estradiol; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• José Bines, MD, PhD

  Instituto Nacional de Cancer, Brazil

  STUDY CHAIR

• Jason Carroll, PhD

  Cancer Research UK Cambridge Institute

  STUDY CHAIR

Central Study Contacts

Renata Obadia, RN

CONTACT

552132073810; robadia@inca.gov.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 19, 2017
• Study Start: March 6, 2017
• Primary Completion: March 1, 2020
• Study Completion: September 1, 2020
• Last Updated: August 15, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)