- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03024580
A Study Evaluating Megestrol Acetate Modulation in Hormone Receptor Positive Advanced Breast Cancer (MEGA)
A Pilot Study Evaluating Megestrol Acetate Modulation in Advanced Breast Cancer With Positive Hormonal Receptor
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Renata Obadia, RN
- Phone Number: 552132073810
- Email: robadia@inca.gov.br
Study Locations
-
-
-
Rio de Janeiro, Brazil, 20560120
- Recruiting
- Hospital do Cancer III
-
Contact:
- Renata Obadia, RN
- Phone Number: 552132073810
- Email: robadia@inca.gov.br
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
Megestrol acetate 160 mg PO daily
Other Names:
|
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.
|
Anastrozole 1 mg PO daily OR
Other Names:
|
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.
|
Letrozole 2.5 mg PO daily OR
Other Names:
|
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.
|
Exemestane 25 mg PO daily
Other Names:
|
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.
|
Tamoxifen 20 mg PO daily
Other Names:
|
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.
|
Fulvestrant 500 mg IM d1, d14, d28 and q28 days
Other Names:
|
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
Collaborators
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
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Estrogen Receptor Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Central Nervous System Stimulants
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Appetite Stimulants
- Letrozole
- Fulvestrant
- Tamoxifen
- Anastrozole
- Exemestane
- Megestrol
- Megestrol Acetate
Other Study ID Numbers
- 64/16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Breast Neoplasm
-
Baylor College of MedicineThe Methodist Hospital Research Institute; Center for Cell and Gene Therapy...Not yet recruitingBreast Cancer | Neoplasm, Breast | Malignant Neoplasm of Breast | Breast Tumor | Mammary Cancer | Mammary Neoplasms, Human | Tumor, Breast | Mammary NeoplasmUnited States
-
National Cancer Institute (NCI)RecruitingAdvanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Triple-Negative Breast CarcinomaUnited States
-
Jonsson Comprehensive Cancer CenterU.S. Army Medical Research and Development Command; U.S. Army Medical Research...CompletedBreast Carcinoma | Malignant Breast Neoplasm | Benign Breast NeoplasmUnited States
-
National Cancer Institute (NCI)RecruitingAdvanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | HER2-Positive Breast CarcinomaUnited States
-
Indiana UniversityIndiana University HealthCompletedBreast Cancer | Breast Neoplasms | Anxiety | Breast Carcinoma | Fear | Cancer of Breast | Malignant Tumor of Breast | Malignant Neoplasm of Breast | Mammary Cancer | Human Mammary Carcinoma | Mammary Neoplasm, Human | Mammary Carcinoma | Neoplasm Remission, Spontaneous | Spontaneous Neoplasm Regression | Regression,... and other conditionsUnited States
-
National Cancer Institute, ThailandCompleted
-
Umbria Bioengineering TechnologiesToscana Life Sciences Sviluppo s.r.l.; London South Bank University; ELAROS 24... and other collaboratorsRecruitingWomen's Health: Neoplasm of BreastItaly, Spain, Poland, Portugal, Switzerland
-
Istanbul Aydın UniversityActive, not recruiting
-
University of OviedoCompletedWomen's Health: Neoplasm of BreastSpain
-
National Cancer Institute, ThailandCompleted
Clinical Trials on Megestrol Acetate 160Mg Tablet
-
Southwest Oncology GroupNational Cancer Institute (NCI)CompletedBreast Cancer | Hot Flashes
-
Xiaojun ChenZhejiang Cancer Hospital; Fudan University; Shanghai 6th People's Hospital; Shanghai...CompletedEndometrial Adenocarcinoma | Endometrial Atypical HyperplasiaChina
-
Luye Pharma Group Ltd.RecruitingGeneralized Anxiety DisorderChina
-
Xiaojun ChenRecruitingOverweight | Fertility Issues | Obese | Endometrial CarcinomaChina
-
Children's Hospital of Fudan UniversityCompletedIdiopathic Precocious PubertyChina
-
Par Pharmaceutical, Inc.PRA Health SciencesTerminatedAnorexia | Weight Loss | CachexiaUnited States
-
Bristol-Myers SquibbCompletedHIV Infections | Anorexia | CachexiaUnited States
-
Endo PharmaceuticalsQuintiles, Inc.CompletedHIV Infections | Anorexia | Cachexia | HIV Wasting Syndrome | AIDS Wasting SyndromeUnited States, India, South Africa
-
Bristol-Myers SquibbCompletedHIV Infections | Anorexia | CachexiaUnited States
-
Fudan UniversityPeking Union Medical College HospitalRecruitingEndometrial Neoplasm Malignant Stage IChina