Breast NeoplasmPhase 2MEGANCT03024580
A Study Evaluating Megestrol Acetate Modulation in Hormone Receptor Positive Advanced Breast Cancer
A Phase 2 study testing Megestrol Acetate 160Mg Tablet, Anastrozole 1Mg Tablet and Letrozole 2.5Mg Tablet in people with Breast Neoplasm, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
Trial summary
This pilot trial evaluates in vivo megestrol acetate (MA) modulation of steroidal receptors in advanced breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Megestrol Acetate 160Mg Tablet, Anastrozole 1Mg Tablet and Letrozole 2.5Mg Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Mar 2017to Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Metastatic breast cancer with ER and/or PR positive (primary tumor)
- Metastatic site amenable to biopsy
Who cannot join
- Platelet count below 100,000 / mm3
- Renal or hepatic impairment
- Coagulation disorder
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital do Cancer III
Rio de Janeiro, 20560120
Renata Obadia, RN, 552132073810, robadia@inca.gov.br
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Neoplasm
- Being tested
- Megestrol Acetate 160Mg Tablet, Anastrozole 1Mg Tablet, Letrozole 2.5Mg Tablet, Exemestane 25 MG, Tamoxifen 20Mg Tablet
- Keywords
- Megestrol Acetate, Steroid, Receptors
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Megestrol Acetate 160Mg TabletDrug
Also called MA
Megestrol acetate 160 mg PO daily
Anastrozole 1Mg TabletDrug
Also called Anastrozole
Anastrozole 1 mg PO daily OR
Letrozole 2.5Mg TabletDrug
Also called Letrozole
Letrozole 2.5 mg PO daily OR
Exemestane 25 MGDrug
Also called Exemestane
Exemestane 25 mg PO daily
Tamoxifen 20Mg TabletDrug
Also called Tamoxifen
Tamoxifen 20 mg PO daily
Fulvestrant 50Mg Solution for InjectionDrug
Also called Fulvestrant
Fulvestrant 500 mg IM d1, d14, d28 and q28 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Fulvestrant 50Mg Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 the date of death from any cause, assessed up to 18 months
Measured: From date of randomization until death, assessed up to 18 months
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
Measured: Partial response and stable disease for more than 24 weeks, assessed up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start6 Mar 2017
- Primary completionMar 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancer, Brazil
- Sponsor type
- Other government
- Collaborators
- Cancer Research UK Cambridge Institute
- Responsible party
- Sponsor
- Investigators
- José Bines, MD, PhD, Study chair, Instituto Nacional de Cancer, BrazilJason Carroll, PhD, Study chair, Cancer Research UK Cambridge Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024580
- Sponsor's protocol ID
- 64/16
- Acronym
- MEGA
- Status last verified
- Aug 2019
- First submitted
- 4 Jan 2017
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating Megestrol Acetate Modulation in Advanced Breast Cancer With Positive Hormonal Receptor
- ClinicalTrials.gov ID
- NCT03024580
- Acronym / sponsor ID
- MEGA / 64/16
- Conditions
- Breast Neoplasm
- Keywords
- Megestrol Acetate, Steroid, Receptors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancer, BrazilOther government
- Collaborators
- Cancer Research UK Cambridge Institute
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot trial evaluates in vivo megestrol acetate (MA) modulation of steroidal receptors in advanced breast cancer.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Megestrol acetate | Experimental | Drug: Megestrol Acetate 160Mg TabletMegestrol 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. |
| Anastrozole | Active comparator | Drug: Anastrozole 1Mg TabletAnastrozole 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. |
| Letrozole | Active comparator | Drug: Letrozole 2.5Mg TabletLetrozole 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. |
| Exemestane | Active comparator | Drug: Exemestane 25 MGExemestane 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. |
| Tamoxifen | Active comparator | Drug: Tamoxifen 20Mg TabletTamoxifen 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. |
| Fulvestrant | Active comparator | Drug: Fulvestrant 50Mg Solution for InjectionFulvestrant 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Metastatic breast cancer with ER and/or PR positive (primary tumor)
- Metastatic site amenable to biopsy
Key exclusion criteria (3 listed)
- Platelet count below 100,000 / mm3
- Renal or hepatic impairment
- Coagulation disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Megestrol Acetate 160Mg TabletAlso: MAMegestrol acetate 160 mg PO daily | Drug | Megestrol acetate |
| Anastrozole 1Mg TabletAlso: AnastrozoleAnastrozole 1 mg PO daily OR | Drug | Anastrozole |
| Letrozole 2.5Mg TabletAlso: LetrozoleLetrozole 2.5 mg PO daily OR | Drug | Letrozole |
| Exemestane 25 MGAlso: ExemestaneExemestane 25 mg PO daily | Drug | Exemestane |
| Tamoxifen 20Mg TabletAlso: TamoxifenTamoxifen 20 mg PO daily | Drug | Tamoxifen |
| Fulvestrant 50Mg Solution for InjectionAlso: FulvestrantFulvestrant 500 mg IM d1, d14, d28 and q28 days | Drug | Fulvestrant |
Primary outcome
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
2 secondary outcomes
Overall survival
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Bines, MD, PhD study chair
Instituto Nacional de Cancer, Brazil
Jason Carroll, PhD study chair
Cancer Research UK Cambridge Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Megestrol Acetate 160Mg Tablet, Anastrozole 1Mg Tablet and Letrozole 2.5Mg Tablet in people with Breast Neoplasm, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renata Obadia, RN (552132073810, robadia@inca.gov.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: From date of randomization until disease progression or death due to any cause, assessed up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.