Metastatic Breast CancerPhase 2NCT01990209
Orteronel as Monotherapy in Patients With Metastatic Breast Cancer (MBC) That Expresses the Androgen Receptor (AR)
A Phase 2 study testing Orteronel in people with Metastatic Breast Cancer, run by SCRI Development Innovations, LLC at 10 sites in United States.
Trial summary
The androgen receptor (AR) is expressed in 70-90 percent of primary breast tumors and in 75 percent of breast metastases. There is evidence to suggest that Androgen Receptor (AR) may be a target in patients with advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Orteronel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 10 sitesUnited States
- Study dates
- Mar 2014to 1 May 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care
- Patients must have MBC that is measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Patients with metastases limited to the bones are eligible.
- Patients with breast tumors that are AR+ (≥10% staining by immunohisto-chemistry). Archived tumor tissue from a primary biopsy or metastatic lesion for centralized determination of AR expression is mandatory. If tissue is limited, the additional correlative testing is optional. If tissue is not available, a patient will not be eligible for enrollment into the study. Patients may enroll based on local laboratory AR assessment, but will need to submit tissue for confirmation at the central laboratory.
- In addition to having AR+ tumors, patients must fit into 1 of the 2 following categories:
- Triple negative (ER-/PR-/HER2-) (Note: This group of patients must have received at least 1 and up to 3 prior chemotherapy regimens in the advanced setting.)
- ER+ and/or PR+ (Note: This group of patients must have received at least 1 and up to 3 prior hormonal therapies and at least one prior chemotherapy treatment in the advanced setting. HER2+ patients in this group must have received a minimum of 2 lines of HER2-directed therapy in the advanced setting.) This group of patients may be pre-menopausal with ovarian suppression or post-menopausal. LHRH agonists maybe used to render ovarian suppression with post-menopausal ranges of estradiol or FSH per institutional guidelines.
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- Female or male patients ≥18 years-of-age
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Patient has recovered (to Grade ≤1) from all clinically significant toxicities related to prior antineoplastic therapies (with the exception of alopecia)
- Adequate hematological function, defined as:
- Absolute neutrophil count (ANC) ≥1.25 x 109/L
- Platelets ≥75 x 109/L
- Hemoglobin ≥9 g/dL
- Adequate liver function, defined as:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x the upper limit of normal (ULN), if no liver involvement or ≤5 x ULN with liver involvement
- Total bilirubin ≤1.5 times the upper limit of normal (ULN) (in patients with known Gilbert Syndrome, a total bilirubin ≤3.0 x ULN, with direct bilirubin ≤1.5 x ULN)
- Adequate renal function, defined as:
- Creatinine ≤1.5 x ULN or creatinine clearance ≥40 mL/min as calculated by the Cockcroft-Gault method
- Screening calculated LVEF of ≥50% by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan
- Ability to swallow and retain oral medication
- Male patients (even those post vasectomy) who are willing to use adequate contraceptive measures or abstain from heterosexual intercourse during the entire study treatment period and for 4 months after the last dose of study drug
- Female patients who are not of child-bearing potential and female patients of child-bearing potential who agree to use adequate contraceptive measures or abstain from heterosexual intercourse during the entire study treatment period and for 4 months after the last dose of study drug, who are not breastfeeding, and who have had a negative serum/urine pregnancy test ≤7 days prior to dosing
- Life expectancy of ≥3 months
- Willingness and ability to understand the nature of this study and to comply with the study and follow-up procedures.
Who cannot join
- Known hypersensitivity to orteronel or to orteronel excipients, which are listed by formulation in the Investigator Brochure
- Patients receiving other treatment for breast cancer (includes standard hormonal therapy, chemotherapy, biologic therapy, immunotherapy, or radiation therapy). Patients receiving chronic bisphosphonate or denosumab therapy are eligible.
- Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period.
- Prior anti-androgen therapy
- Use of an investigational drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of orteronel, or concurrent treatment. For investigational drugs for which 5 half-lives is less than 21 days, a minimum of 10 days between termination of the investigational drug and administration of orteronel is required.
- Active brain metastases or leptomeningeal disease. Previously treated brain metastases are allowed provided lesions are stable for at least 3 months as documented by head CT scan or magnetic resonance imaging (MRI) of the brain. Patients must be off steroids, but anti-convulsants are allowed.
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- Patients with known adrenal insufficiency, or patients receiving treatment with ketoconazole, abiraterone, or aminoglutethimide.
- Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study drug or has not recovered from side effects of such therapy.
- Major surgical procedures ≤28 days of beginning study treatment or minor surgical procedures ≤7 days. No waiting is required following port-a-cath placement.
- Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (eg, ulcerative disease, uncontrolled nausea, vomiting, diarrhea ≥ Grade 2, and malabsorption syndrome).
- History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias > Grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0), thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (eg, pericardial effusion restrictive cardiomyopathy) within 6 months prior to first dose of study drug. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
- New York Heart Association (NYHA) Class III or IV heart failure
- Electrocardiogram (ECG) abnormalities of Q-wave infarction, unless identified 6 or more months prior to screening or QTc Fridericia (F) interval >460 msec
- Inadequately controlled hypertension (ie, systolic blood pressure [SBP] >160 mmHg or diastolic BP [DBP] >90 mmHg) at 2 separate measurements no more than 60 minutes apart during the Screening visit. Note: patients may be rescreened after adjustment of antihypertensive medications.
- Known diagnosis of human immunodeficiency virus, active chronic hepatitis B, or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study
- Uncontrolled diabetes mellitus. Patients with Type II diabetes are eligible if they require only oral hypoglycemic agents and fasting blood glucose level is ≤120. Patients with Type I diabetes are eligible if their glycosylated hemoglobin (HbAlc) is ≤7.
- Diagnosis or treatment for another malignancy within 2 years of enrollment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer
- Inability or unwillingness (including psychological, familial, sociological, or geographical conditions) to comply with study and/or follow-up procedures as outlined in the protocol.
- Use of a prohibited concomitant medication that cannot be safely discontinued or substituted.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Tennessee Oncology PLLC
Chattanooga, Tennessee, 37404
Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, 49503
Cancer Centers of SW Oklahoma
Lawton, Oklahoma, 73505
Baptist Hospital East
Louisville, Kentucky, 40207
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
Yale School of Medicine
New Haven, Connecticut, 06520
Hope Cancer Center
Terre Haute, Indiana, 47802
About this study
Official title: A Phase II Study With Orteronel as Monotherapy in Patients With Metastatic Breast Cancer (MBC) That Expresses the Androgen Receptor (AR)
The androgen receptor (AR) is expressed in 70-90 percent of primary breast tumors and in 75 percent of breast metastases. There is evidence to suggest that Androgen Receptor (AR) may be a target in patients with advanced breast cancer. Breast cancer patients whose tumors do not express the ER, PR or HER2 (triple negative) have very few options for treatment. Orteronel is being developed as an endocrine therapy for relevant hormone-sensitive cancers such as prostrate cancer and breast cancer. Triple-negative metastatic breast cancer patients with AR expression could potentially benefit from anti-androgen therapy like orteronel.
Read the detailed description
This open-label multicenter study will be conducted in 2 stages.
- Lead-in Phase: The first 6 patients treated will be evaluated to confirm the safety and feasibility of this regimen. After all 6 patients complete at least 4 weeks of treatment, and if no prohibitive toxicities are identified, continuous study treatment will begin.
- Continuous Study Treatment: Patients will continue to be enrolled into both cohorts based on their tumor specificities with an anticipated total of 31 patients in Cohort 1 (ER-/PR-/HER2-/AR+) and an anticipated total of 55 patients in Cohort 2 (ER+ and/or PR+/AR+).
Patients will be evaluated every eight weeks for response to treatment. All patients who respond to treatment (complete response [CR] or partial response [PR]) or have stable disease (SD) will continue to receive orteronel until they develop progressive disease (PD) or unacceptable toxicity.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Orteronel
- Keywords
- triple-negative breast cancer, orteronel, TAK-700, metastatic breast cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrteronelDrug
Also called Tak-700
| Study group | Role | What they receive |
|---|---|---|
| Orteronel | Experimental | The planned dose of orteronel is 300mg orally (PO) twice daily (BID), for a total daily dose of 600mg. Receives: Drug: Orteronel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate (RR)
Response rate (RR) will be estimated as the percentage of patients exhibiting complete response or partial response out of all evaluable cases. Complete Response is defined per RECIST as the disappearance of all target/non-target lesions and normalization of tumor markers. Partial Response is defined per RECIST as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete and partial responses were confirmed at least 4 weeks after the initial response.
Measured: upto 36 months
Disease Control Rate (DCR)
Defined as the percentage of patients who do not exhibit progression (CR+PR+SD) at 6 months among those patients who are evaluable for response by RECIST V1.1. Complete Response is defined per RECIST as the disappearance of all target/non-target lesions and normalization of tumor markers. Partial Response is defined per RECIST as At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease is defined per RECIST as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest (nadir) sum LD since the treatment started.
Measured: 6 months
Secondary outcomes (10)
Number of Participants With Treatment-Related Adverse Events as a Measure of Safety
Assessments will be made through analysis of the reported incidence of treatment-related Adverse Events as determined by the investigator and assessed by NCI CTCAE, Version 4.0.
Measured: weekly for 4 weeks then every 8 weeks until end of study treatment, up to 36 months.
Progression-free Survival (PFS)
Progression-free survival is defined as the time from the first day of treatment until the day tumor progression or date of death was documented. The response was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Measured: Every 8 weeks during treatment then every 6 months for 2 years, annually thereafter up to 5 years.
Overall Survival (OS)
OS is defined as the time from the first treatment until the date of death due to any cause. In the absence of confirmation of death or lack of data beyond the follow-up period, the survival time was censored to the last date the participant was known to be alive.
Measured: After disease progression is documented, survival was monitored every 6 months for 2 years and annually thereafter up to 5 years.
Measurement of Serum Hormone Levels - Estradiol
Blood samples collected At baseline, at day 1 of cycle 2 and 4, and at end of treatment visit to test for serum estradiol levels
Measured: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 months
Measurement of Serum Hormone Levels - Total Testosterone
Blood samples were collected at baseline, on day 1 of cycles 2 and 4, and at end of treatment visit to test total testosterone levels
Measured: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 months
Measurement of Serum Hormone Levels - Free Testosterone
Blood samples were collected At baseline, at day 1 of cycle 2 and 4, and at end of treatment visit to test free testosterone levels
Measured: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 months
Measurement of Serum Hormone Levels - Sex Hormone-binding Globulin
Blood samples were collected at baseline, on day 1 of cycles 2 and 4, and at end of the treatment visit for sex hormone-binding globulin (SHBG) levels
Measured: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 months
Measurement of Serum Hormone Levels - Adrenocorticotropic Hormone
Blood samples were collected at baseline, on day 1 of cycles 2 and 4, and at end of the treatment visit to test for adrenocorticotropic hormone (ACTH) levels
Measured: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 months
Measurement of Serum Hormone Levels - Dehydroepiandrosterone Sulfate (DHEA-S)
Blood samples were collected at baseline, on day 1 of cycles 2 and 4, and at end of the treatment visit dehydroepiandrosterone sulfate (DHEA-S) levels
Measured: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 months
Measurement of Serum Hormone Levels - Cortisol
Blood samples to test for serum cortisol levels
Measured: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startMar 2014
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Breast CancerStudies 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Howard A Burris, III, MD, Study chair, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990209
- Sponsor's protocol ID
- SCRI BRE 203
- Status last verified
- Jun 2022
- First submitted
- 8 Nov 2013
- Last updated
- 30 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study With Orteronel as Monotherapy in Patients With Metastatic Breast Cancer (MBC) That Expresses the Androgen Receptor (AR)
- ClinicalTrials.gov ID
- NCT01990209
- Acronym / sponsor ID
- SCRI BRE 203
- Conditions
- Metastatic Breast Cancer
- Keywords
- triple-negative breast cancer, orteronel, TAK-700, metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Mar 2014
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Posted 30 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The androgen receptor (AR) is expressed in 70-90 percent of primary breast tumors and in 75 percent of breast metastases. There is evidence to suggest that Androgen Receptor (AR) may be a target in patients with advanced breast cancer. Breast cancer patients whose tumors do not express the ER, PR or HER2 (triple negative) have very few options for treatment. Orteronel is being developed as an endocrine therapy for relevant hormone-sensitive cancers such as prostrate cancer and breast cancer. Triple-negative metastatic breast cancer patients with AR expression could potentially benefit from anti-androgen therapy like orteronel.
Detailed description
This open-label multicenter study will be conducted in 2 stages.
- Lead-in Phase: The first 6 patients treated will be evaluated to confirm the safety and feasibility of this regimen. After all 6 patients complete at least 4 weeks of treatment, and if no prohibitive toxicities are identified, continuous study treatment will begin.
- Continuous Study Treatment: Patients will continue to be enrolled into both cohorts based on their tumor specificities with an anticipated total of 31 patients in Cohort 1 (ER-/PR-/HER2-/AR+) and an anticipated total of 55 patients in Cohort 2 (ER+ and/or PR+/AR+).
Patients will be evaluated every eight weeks for response to treatment. All patients who respond to treatment (complete response [CR] or partial response [PR]) or have stable disease (SD) will continue to receive orteronel until they develop progressive disease (PD) or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orteronel | Experimental | Drug: OrteronelThe planned dose of orteronel is 300mg orally (PO) twice daily (BID), for a total daily dose of 600mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care
- Patients must have MBC that is measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Patients with metastases limited to the bones are eligible.
- Patients with breast tumors that are AR+ (≥10% staining by immunohisto-chemistry). Archived tumor tissue from a primary biopsy or metastatic lesion for centralized determination of AR expression is mandatory. If tissue is limited, the additional correlative testing is optional. If tissue is not available, a patient will not be eligible for enrollment into the study. Patients may enroll based on local laboratory AR assessment, but will need to submit tissue for confirmation at the central laboratory.
- In addition to having AR+ tumors, patients must fit into 1 of the 2 following categories:
- Female or male patients ≥18 years-of-age
Key exclusion criteria (19 listed)
- Known hypersensitivity to orteronel or to orteronel excipients, which are listed by formulation in the Investigator Brochure
- Patients receiving other treatment for breast cancer (includes standard hormonal therapy, chemotherapy, biologic therapy, immunotherapy, or radiation therapy). Patients receiving chronic bisphosphonate or denosumab therapy are eligible.
- Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period.
- Prior anti-androgen therapy
- Use of an investigational drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of orteronel, or concurrent treatment. For investigational drugs for which 5 half-lives is less than 21 days, a minimum of 10 days between termination of the investigational drug and administration of orteronel is required.
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 |
|---|---|---|
| OrteronelAlso: Tak-700 | Drug | Orteronel |
Primary outcome
Response Rate (RR)
Time frame: upto 36 months
Response rate (RR) will be estimated as the percentage of patients exhibiting complete response or partial response out of all evaluable cases. Complete Response is defined per RECIST as the disappearance of all target/non-target lesions and normalization of tumor markers. Partial Response is defined per RECIST as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete and partial responses were confirmed at least 4 weeks after the initial response.
Disease Control Rate (DCR)
Time frame: 6 months
Defined as the percentage of patients who do not exhibit progression (CR+PR+SD) at 6 months among those patients who are evaluable for response by RECIST V1.1. Complete Response is defined per RECIST as the disappearance of all target/non-target lesions and normalization of tumor markers. Partial Response is defined per RECIST as At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease is defined per RECIST as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest (nadir) sum LD since the treatment started.
10 secondary outcomes
Number of Participants With Treatment-Related Adverse Events as a Measure of Safety
Time frame: weekly for 4 weeks then every 8 weeks until end of study treatment, up to 36 months.
Progression-free Survival (PFS)
Time frame: Every 8 weeks during treatment then every 6 months for 2 years, annually thereafter up to 5 years.
Overall Survival (OS)
Time frame: After disease progression is documented, survival was monitored every 6 months for 2 years and annually thereafter up to 5 years.
Measurement of Serum Hormone Levels - Estradiol
Time frame: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 months
Measurement of Serum Hormone Levels - Total Testosterone
Time frame: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 months
Measurement of Serum Hormone Levels - Free Testosterone
Time frame: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 months
Measurement of Serum Hormone Levels - Sex Hormone-binding Globulin
Time frame: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 months
Measurement of Serum Hormone Levels - Adrenocorticotropic Hormone
Time frame: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 months
Measurement of Serum Hormone Levels - Dehydroepiandrosterone Sulfate (DHEA-S)
Time frame: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 months
Measurement of Serum Hormone Levels - Cortisol
Time frame: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Howard A Burris, III, MD study chair
SCRI Development Innovations, LLC
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Orteronel in people with Metastatic Breast Cancer, run by SCRI Development Innovations, LLC at 10 sites in United States.
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 24 inclusion and 19 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: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Yes. Results are posted in the registry (first posted 30 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (RR) (time frame: upto 36 months). The study lists 2 primary outcomes in all. 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 30 Jun 2022.