Hormone Receptor Positive Malignant Neoplasm of BreastPhase 2NCT02025712
Exemestane Plus Everolimus for Hormone-receptor Positive Metastatic Breast Cancer
A Phase 2 study testing Exemestane and Everolimus in people with Hormone Receptor Positive Malignant Neoplasm of Breast, run by Organisation for Oncology and Translational Research at 1 site in China.
Trial summary
The purpose of this study is to determine whether exemestane plus everolimus are effective in the treatment of patients who have achieved disease stabilization after induction chemotherapy for hormone-receptor positive metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hormone Receptor Positive Malignant Neoplasm of Breast
- What is being tested?
- Exemestane and Everolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- Start not givento Aug 2016
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women as defined in the protocol page 9;
- Histologically and/or cytologically confirmed invasive breast cancer with stage IV disease according to AJCC;
- Confirmed ER/PR-positive, and HER-2 negative tumor;
- Disease progression on or following prior endocrine therapy with tamoxifen or non-steroidal aromatase inhibitor, as defined in protocol, prior to standard of care (SOC) induction chemotherapy
- Patient with documented evidence of visceral disease (including but not limited to hepatic involvement and pulmonary lymphangitic spread of tumor) with sign(s) and/or symptom(s) prior to SOC induction chemotherapy should achieve disease stabilization after the SOC induction chemotherapy, confirmed upon 2 consecutive routine tumor assessments;
- ECOG performance status ≤ 2 or Karnofsky performance status ≥ 50% prior to the start of study treatment;
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- Adequate organ function prior to the start of study treatment as defined in the protocol;
- Able to swallow and retain oral medication;
- Able to give written informed consent;
Who cannot join
- Male patient;
- Metastatic disease limited to the bone or soft tissues only and with no history of other visceral metastases;
- History of brain or other CNS metastases;
- Previous treatment with exemestane, unless exemestane was administered in the adjuvant setting and stopped >1 year before metastatic relapse;
- Untreated with SOC chemotherapy for invasive breast cancer with stage IV disease according to AJCC - or - treated with SOC chemotherapy for invasive breast cancer with stage IV disease according to AJCC without clinical benefit;
- History of neurological or psychiatric disorders;
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- Any serious cardiovascular diseases in the previous 6 months;
- Impairment of gastrointestinal function or gastrointestinal disease;
- Patients with uncontrolled infection;
- Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin defined as 1 mg a day);
- Chronic treatment with systemic steroids or another immunosuppressive agent;
- Patients with a pre-existing peripheral neuropathy > grade 1;
- Patients who are hepatitis B and/or hepatitis C carriers;
- Known human immunodeficiency virus infection;
- Prior exposure to mTOR inhibitors;
- Hypersensitivity to rapamycin or other similar compounds;
- Patients taking medications known to be inhibitors or inducers of CYP3A4 and/or PgP will not be included in this study;
- Prior treatment with any investigational agent within the preceding 4 weeks;
- Other conditions in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
Louis Chow, MD contact
China1 site
Unimed Medical Institute
Hong Kong
Louis Chow, (852)28610286
Louis Chow
About this study
Official title: A Phase II Open-label Pilot Study Evaluating the Maintenance Therapy With Exemestane Plus Everolimus After Induction Chemotherapy in Patients With Hormone-receptor Positive Metastatic Breast Cancer
The purpose of this study is to determine whether exemestane plus everolimus are effective in the treatment of patients who have achieved disease stabilization after induction chemotherapy for hormone-receptor positive metastatic breast cancer.
Read the detailed description
Postmenopausal women with HR-positive, HER2-negative metastatic breast cancer achieving clinical benefit after the induction chemotherapy for visceral disease with sign(s) and/or symptom(s) will be recruited to receive study the maintenance treatment of everolimus plus exemestane.
- Being tested
- Exemestane, Everolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExemestaneDrug
Also called Aromasin
Commercially available exemestane was supplied to sites as 25-mg tablets according to local regulations.
EverolimusDrug
Also called Afinitor, RAD001
Everolimus was administered by continuous oral dosing of two 5-mg tablets or one 10-mg tablets.
| Study group | Role | What they receive |
|---|---|---|
| Exemestane plus Everolimus | Experimental | Exemestane 25 mg daily in combination with Everolimus 10 mg daily until disease progression or intolerable toxicity Receives: Drug: Exemestane; Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
defined as from date of treatment initiation with everolimus plus exemestane to the date of progression or death if no documented disease progression
Measured: Every 8 weeks in the first 24 weeks of treatment and every 12 weeks thereafter, up to 8 months (estimated)
Secondary outcomes (4)
Response rate
Measured: Every 8 weeks, up to 8 months (estimated)
Clinical benefit rate
Measured: Every 8 weeks, up to 8 months (estimated)
Overall survival
Measured: date of treatment initiation with everolimus plus exemestane until the date of death, censored at the last date known alive, whichever came first, assessed up to 32 months
Incidence of Adverse Events (AEs)/Serious Adverse Events (SAEs)
Measured: Continuous during the study, up to 28 days after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Primary completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Receptor Positive Malignant Neoplasm of BreastStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Organisation for Oncology and Translational Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis Chow, Principal investigator, Organisation for Oncology and Translational Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025712
- Sponsor's protocol ID
- M004/EXE-EVE
- Status last verified
- Dec 2013
- First submitted
- 16 Dec 2013
- Last updated
- 1 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open-label Pilot Study Evaluating the Maintenance Therapy With Exemestane Plus Everolimus After Induction Chemotherapy in Patients With Hormone-receptor Positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02025712
- Acronym / sponsor ID
- M004/EXE-EVE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Organisation for Oncology and Translational ResearchUniversity, hospital or other
- Primary completion
- Aug 2016 (estimated)
- First posted
- 1 Jan 2014 (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.
The purpose of this study is to determine whether exemestane plus everolimus are effective in the treatment of patients who have achieved disease stabilization after induction chemotherapy for hormone-receptor positive metastatic breast cancer.
Detailed description
Postmenopausal women with HR-positive, HER2-negative metastatic breast cancer achieving clinical benefit after the induction chemotherapy for visceral disease with sign(s) and/or symptom(s) will be recruited to receive study the maintenance treatment of everolimus plus exemestane.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exemestane plus Everolimus | Experimental | Drug: Exemestane, Drug: EverolimusExemestane 25 mg daily in combination with Everolimus 10 mg daily until disease progression or intolerable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Postmenopausal women as defined in the protocol page 9;
- Histologically and/or cytologically confirmed invasive breast cancer with stage IV disease according to AJCC;
- Confirmed ER/PR-positive, and HER-2 negative tumor;
- Disease progression on or following prior endocrine therapy with tamoxifen or non-steroidal aromatase inhibitor, as defined in protocol, prior to standard of care (SOC) induction chemotherapy
- Patient with documented evidence of visceral disease (including but not limited to hepatic involvement and pulmonary lymphangitic spread of tumor) with sign(s) and/or symptom(s) prior to SOC induction chemotherapy should achieve disease stabilization after the SOC induction chemotherapy, confirmed upon 2 consecutive routine tumor assessments;
Key exclusion criteria (20 listed)
- Male patient;
- Metastatic disease limited to the bone or soft tissues only and with no history of other visceral metastases;
- History of brain or other CNS metastases;
- Previous treatment with exemestane, unless exemestane was administered in the adjuvant setting and stopped >1 year before metastatic relapse;
- Untreated with SOC chemotherapy for invasive breast cancer with stage IV disease according to AJCC - or - treated with SOC chemotherapy for invasive breast cancer with stage IV disease according to AJCC without clinical benefit;
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 |
|---|---|---|
| ExemestaneAlso: AromasinCommercially available exemestane was supplied to sites as 25-mg tablets according to local regulations. | Drug | Exemestane plus Everolimus |
| EverolimusAlso: Afinitor, RAD001Everolimus was administered by continuous oral dosing of two 5-mg tablets or one 10-mg tablets. | Drug | Exemestane plus Everolimus |
Primary outcome
Progression Free Survival
Time frame: Every 8 weeks in the first 24 weeks of treatment and every 12 weeks thereafter, up to 8 months (estimated)
defined as from date of treatment initiation with everolimus plus exemestane to the date of progression or death if no documented disease progression
4 secondary outcomes
Response rate
Time frame: Every 8 weeks, up to 8 months (estimated)
Clinical benefit rate
Time frame: Every 8 weeks, up to 8 months (estimated)
Overall survival
Time frame: date of treatment initiation with everolimus plus exemestane until the date of death, censored at the last date known alive, whichever came first, assessed up to 32 months
Incidence of Adverse Events (AEs)/Serious Adverse Events (SAEs)
Time frame: Continuous during the study, up to 28 days after the last treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2014.
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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.
Louis Chow, MD contact
Louis Chow principal investigator
Organisation for Oncology and Translational Research
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 Exemestane and Everolimus in people with Hormone Receptor Positive Malignant Neoplasm of Breast, run by Organisation for Oncology and Translational Research at 1 site in China.
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 9 inclusion and 20 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 1 Jan 2014. 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 China. 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 Louis Chow, MD ((852)28610286), 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: Every 8 weeks in the first 24 weeks of treatment and every 12 weeks thereafter, up to 8 months (estimated)). 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 1 Jan 2014.