Metastatic Breast CancerPhase 1NCT05508906
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
A Phase 1 study testing Palazestrant, Ribociclib and Alpelisib in people with Metastatic Breast Cancer and ER-positive Breast Cancer, run by Olema Pharmaceuticals, Inc. at 16 sites in 2 countries.
Trial summary
This is a Phase 1b open-label, 2-part study in 4 treatment groups. The 4 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer
- What is being tested?
- Palazestrant, Ribociclib and Alpelisib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 31 Aug 2022to 31 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Female or male aged >18 years.
- Willing and able to participate and comply with all study requirements.
- Histologically- or cytologically-confirmed advanced or metastatic Breast Cancer (mBC).
- ER+/HER2- disease, as determined in the most recently obtained archival tumor tissue sample from a metastatic site, using locally accepted criteria by the local pathology report.
- Evaluable disease with one of the following: Measurable disease, ie, at least 1 measurable lesion as per RECIST 1.1 (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation) OR patients with predominantly bone disease (with or without other non-measurable lesions) are allowed if it is possible to evaluate on radiological examinations (eg. bone scan, PET/CT, CT, MRI) even if lesions are non-measurable according to RECIST 1.1.
- Life expectancy ≥6 months, as judged by the investigator.
Show all 9Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Has received no more than 1 prior hormonal regimen (Treatment Group 1). Has received no more than 2 prior hormonal regimens (Treatment Group 2 and Treatment Group 3) . Has received no more than 2 prior hormonal regimens for metastatic disease in Part 1 (Dose Escalation) and no more than 1 prior hormonal regimes in Part 2 (Dose Expansion) for metastatic disease, regardless of type of endocrine agent (Treatment Group 4) for advanced or metastatic disease. Prior hormonal regimens in combination with CDK4/6 inhibitors are allowed in all treatment groups. For subjects in Treatment Group 4, no prior chemotherapy for metastatic breast cancer is allowed.
- Has received no more than 1 prior chemotherapy (which includes antibody drug conjugates) for locally advanced or metastatic breast cancer.
Who cannot join
- Prior or concurrent malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
- History of cerebral vascular disease within 6 months prior to the first administration of study drug dose.
- History of a pulmonary embolism, or deep venous thrombosis within the last 6 months, or subject has an increased risk of thrombosis as determined by the investigator.
- History of pneumonitis or interstitial lung disease.
- Leptomeningeal disease or spinal cord compression.
Show all 14Show fewer
- Medical history or ongoing gastrointestinal disorders that could affect absorption of oral therapeutics.
- Known human immunodeficiency virus infection.
- Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis (eg, hepatitis B or hepatitis C virus), current alcohol abuse, or cirrhosis.
- History of severe cutaneous reaction, such as Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms.
- Active infection or at a high risk of developing a serious infection (e.g. participants with immunodeficiencies, uncontrolled diabetes mellitus, uncontrolled heart disease, poor general health, poor nutritional status).
- Has clinically significant co-morbidities, such as, psychiatric disease, or any other condition that could impact the ability of the subject to participate in this study or otherwise has the potential to confound the study results.
- Have received prior treatment with OP-1250.
- Have received prior treatment with approved or investigational PI3K inhibitor (Treatment Group 2) or mTOR inhibitor (Treatment Group 3).
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States14 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, 28204
Henry Ford Health
Detroit, Michigan, 48126
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Regents of the University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Ichan School of Medicine at Mount Sinai
New York, New York, 10029
Advent Health Hematology and Oncology
Orlando, Florida, 32804
University of California San Francisco Health
San Francisco, California, 94158
Washington University, School of Medicine
St Louis, Missouri, 63110
Northwest Medical Specialties
Tacoma, Washington, 98405
Australia2 sites
Breast Cancer Research Center- Western Australia
Nedlands, Western Australia, 6009
Macquarie Health
Sydney, New South Wales, 2109
About this study
Official title: A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4/6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, With the mTOR Inhibitor Everolimus, or With CDK4 Inhibitor Atirmociclib in Adult Subjects With Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer
This is a Phase 1b open-label, 2-part study in 4 treatment groups. The 4 treatment groups are as follows:
Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).
Treatment Group 2: Palazestrant (OP-1250) in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation).
Treatment Group 3: Palazestrant (OP-1250) in combination with everolimus.
Treatment Group 4: Palazestrant (OP-1250) in combination with atirmociclib.
Read the detailed description
Part 1 (Dose Escalation): This part will evaluate the safety and pharmacokinetics of a range of doses of palazestrant administered orally (PO) daily to subjects in combination with 600 mg of ribociclib administered PO daily for 21 consecutive days followed by 7 days off treatment (Treatment Group 1) or with 300 mg or 250 mg of alpelisib administered PO daily (Treatment Group 2) or with everolimus 10 mg administered PO daily (Treatment Group 3) and determine the RP2D (Recommended Phase 2 Dose) for each treatment group. Part 1, for Treatment Group 4, will evaluate the safety and pharmacokinetics of OP-1250 at 60 mg or 90 mg doses administered orally (PO) QD in combination with atirmociclib 300 mg PO twice a day (BID).
Part 2 (Dose Expansion): This part of the study will further evaluate the safety and PK of palazestrant at the RP2D in combination with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), or everolimus (Treatment Group 3) and provide an exploratory estimate of anti-tumor activity of the combinations. An additional group of palazestrant at an alternate dose level in combination with ribociclib (Treatment Group 1b) will be explored to optimize the RP2D of palazestrant. Part 2, for Treatment Group 4, will further evaluate the safety and pharmacokinetics of atirmociclib and OP-1250 at the recommended dose for expansion.
- Conditions
- Metastatic Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, Breast Cancer, Locally Advanced Breast Cancer
- Being tested
- Palazestrant, Ribociclib, Alpelisib, Everolimus, Atirmociclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalazestrantDrug
Complete estrogen receptor antagonist (CERAN)
RibociclibDrug
Also called KISQALI®, CDK4/6 inhibitor
All subjects in Treatment Group 1 will receive palazestrant in combination with ribociclib.
AlpelisibDrug
Also called PIQRAY®, PI3K Inhibitor
All subjects in Treatment Group 2 will receive palazestrant in combination with alpelisib.
EverolimusDrug
Also called mTOR inhibitor
All subjects in Treatment Group 3 will receive palazestrant in combination with everolimus.
AtirmociclibDrug
Also called CDK4i
All subjects in Treatment Group 4 will receive palazestrant in combination with atirmociclib.
| Study group | Role | What they receive |
|---|---|---|
| Palazestrant with Ribociclib | Experimental | Treatment Group 1: Palazestrant in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation). Receives: Drug: Palazestrant; Drug: Ribociclib |
| Palazestrant with Alpelisib | Experimental | Treatment Group 2: Palazestrant in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation) Receives: Drug: Palazestrant; Drug: Alpelisib |
| Palazestrant with Everolimus | Experimental | Treatment Group 3: Palazestrant in combination with everolimus Receives: Drug: Palazestrant; Drug: Everolimus |
| Palazestrant with Atirmociclib | Experimental | Treatment Group 4: Palazestrant in combination with atirmociclib Receives: Drug: Palazestrant; Drug: Atirmociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLTs)
To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and/ or recommended dose expansion (RDE) of palazestrant when administered with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), or everolimus (Treatment Group 3), or atirmociclib (Treatment Group 4). The incidence of DLTs will be assessed in the Dose Escalation part (Part 1) of the study.
Measured: The first 28 days of treatment
Characterize the incidence, nature and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of palazestrant when administered with ribociclib, alpelisib, everolimus, or atirmociclib.
Characterize the incidence, nature and severity of TEAEs and SAEs of palazestrant when administered with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), everolimus (Treatment Group 3), or atirmociclib (Treatment Group 4) according to NCI-CTCAE version 5.0.
Measured: Up to 30 days after last dose of study drug(s) treatment
Pharmacokinetics (PK) of palazestrant when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2), everolimus (Treatment Group 3), or atirmociclib (Treatment Group 4) .
To assess the PK of palazestrant (and potential metabolites) in combination with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), everolimus (Treatment Group 3), or atirmociclib (Treatment Group 4). Plasma levels of palazestrant will be assessed at predefined intervals to establish PK parameters (including: Cmax, Cmin, Tmax, AUC, and t1⁄2 as data permit) and palazestrant trough concentration at steady state).
Measured: Every 28 days
Secondary outcomes (3)
Preliminarily assess the anti-tumor activity Overall Response Rate of palazestrant when administered with ribociclib, alpelisib, everolimus, or atirmociclib as assessed by the investigator using RECIST v1.1.
Tumor response will be evaluated in patients with measurable or evaluable disease using RECISTv1.1 guidelines.
Measured: Up to 1 year
Evaluate clinical benefit rate (CBR) of palazestrant when administered with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), or everolimus (Treatment Group 3), or atirmociclib (Treatment Group 4).
CBR will be assessed as proportion of subjects achieving complete response (CR), partial response (PR), or stable disease (SD) with duration of at least 24 weeks.
Measured: Up to 1 year
Evaluate duration of response (DoR) of palazestrant when administered with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), everolimus (Treatment Group 3), or atirmociclib (Treatment Group 4).
DoR will be calculated as the number of days from the start date of PR or CR (whichever response is achieved first) to the first date that progressive disease is documented.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start31 Aug 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Treatment Group 1: Palazestrant in combination with ribociclib Treatment Group 2: Palazestrant in combination with alpelisib Treatment Group 3: Palazestrant in combination with everolimus Treatment Group 4: Palazestrant in combination with atirmociclib
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olema Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis, Pfizer
- Responsible party
- Sponsor
- Investigators
- Kenneth Caldwell, MD, Study director, Olema Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508906
- Sponsor's protocol ID
- OP-1250-003
- Status last verified
- Sep 2026
- First submitted
- 16 Aug 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4/6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, With the mTOR Inhibitor Everolimus, or With CDK4 Inhibitor Atirmociclib in Adult Subjects With Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05508906
- Acronym / sponsor ID
- OP-1250-003
- Conditions
- Metastatic Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, Breast Cancer, Locally Advanced Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Olema Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novartis, Pfizer
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 19 Aug 2022 (actual)
- 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 is a Phase 1b open-label, 2-part study in 4 treatment groups. The 4 treatment groups are as follows:
Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).
Treatment Group 2: Palazestrant (OP-1250) in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation).
Treatment Group 3: Palazestrant (OP-1250) in combination with everolimus.
Treatment Group 4: Palazestrant (OP-1250) in combination with atirmociclib.
Detailed description
Part 1 (Dose Escalation): This part will evaluate the safety and pharmacokinetics of a range of doses of palazestrant administered orally (PO) daily to subjects in combination with 600 mg of ribociclib administered PO daily for 21 consecutive days followed by 7 days off treatment (Treatment Group 1) or with 300 mg or 250 mg of alpelisib administered PO daily (Treatment Group 2) or with everolimus 10 mg administered PO daily (Treatment Group 3) and determine the RP2D (Recommended Phase 2 Dose) for each treatment group. Part 1, for Treatment Group 4, will evaluate the safety and pharmacokinetics of OP-1250 at 60 mg or 90 mg doses administered orally (PO) QD in combination with atirmociclib 300 mg PO twice a day (BID).
Part 2 (Dose Expansion): This part of the study will further evaluate the safety and PK of palazestrant at the RP2D in combination with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), or everolimus (Treatment Group 3) and provide an exploratory estimate of anti-tumor activity of the combinations. An additional group of palazestrant at an alternate dose level in combination with ribociclib (Treatment Group 1b) will be explored to optimize the RP2D of palazestrant. Part 2, for Treatment Group 4, will further evaluate the safety and pharmacokinetics of atirmociclib and OP-1250 at the recommended dose for expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Treatment Group 1: Palazestrant in combination with ribociclib Treatment Group 2: Palazestrant in combination with alpelisib Treatment Group 3: Palazestrant in combination with everolimus Treatment Group 4: Palazestrant in combination with atirmociclib
| Arm | Type | Receives |
|---|---|---|
| Palazestrant with Ribociclib | Experimental | Drug: Palazestrant, Drug: RibociclibTreatment Group 1: Palazestrant in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation). |
| Palazestrant with Alpelisib | Experimental | Drug: Palazestrant, Drug: AlpelisibTreatment Group 2: Palazestrant in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation) |
| Palazestrant with Everolimus | Experimental | Drug: Palazestrant, Drug: EverolimusTreatment Group 3: Palazestrant in combination with everolimus |
| Palazestrant with Atirmociclib | Experimental | Drug: Palazestrant, Drug: AtirmociclibTreatment Group 4: Palazestrant in combination with atirmociclib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female or male aged >18 years.
- Willing and able to participate and comply with all study requirements.
- Histologically- or cytologically-confirmed advanced or metastatic Breast Cancer (mBC).
- ER+/HER2- disease, as determined in the most recently obtained archival tumor tissue sample from a metastatic site, using locally accepted criteria by the local pathology report.
- Evaluable disease with one of the following: Measurable disease, ie, at least 1 measurable lesion as per RECIST 1.1 (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation) OR patients with predominantly bone disease (with or without other non-measurable lesions) are allowed if it is possible to evaluate on radiological examinations (eg. bone scan, PET/CT, CT, MRI) even if lesions are non-measurable according to RECIST 1.1.
Key exclusion criteria (14 listed)
- Prior or concurrent malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
- History of cerebral vascular disease within 6 months prior to the first administration of study drug dose.
- History of a pulmonary embolism, or deep venous thrombosis within the last 6 months, or subject has an increased risk of thrombosis as determined by the investigator.
- History of pneumonitis or interstitial lung disease.
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 |
|---|---|---|
| PalazestrantComplete estrogen receptor antagonist (CERAN) | Drug | Palazestrant with Alpelisib, Palazestrant with Atirmociclib, Palazestrant with Everolimus, Palazestrant with Ribociclib |
| RibociclibAlso: KISQALI®, CDK4/6 inhibitorAll subjects in Treatment Group 1 will receive palazestrant in combination with ribociclib. | Drug | Palazestrant with Ribociclib |
| AlpelisibAlso: PIQRAY®, PI3K InhibitorAll subjects in Treatment Group 2 will receive palazestrant in combination with alpelisib. | Drug | Palazestrant with Alpelisib |
| EverolimusAlso: mTOR inhibitorAll subjects in Treatment Group 3 will receive palazestrant in combination with everolimus. | Drug | Palazestrant with Everolimus |
| AtirmociclibAlso: CDK4iAll subjects in Treatment Group 4 will receive palazestrant in combination with atirmociclib. | Drug | Palazestrant with Atirmociclib |
Primary outcome
Dose Limiting Toxicities (DLTs)
Time frame: The first 28 days of treatment
To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and/ or recommended dose expansion (RDE) of palazestrant when administered with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), or everolimus (Treatment Group 3), or atirmociclib (Treatment Group 4). The incidence of DLTs will be assessed in the Dose Escalation part (Part 1) of the study.
Characterize the incidence, nature and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of palazestrant when administered with ribociclib, alpelisib, everolimus, or atirmociclib.
Time frame: Up to 30 days after last dose of study drug(s) treatment
Characterize the incidence, nature and severity of TEAEs and SAEs of palazestrant when administered with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), everolimus (Treatment Group 3), or atirmociclib (Treatment Group 4) according to NCI-CTCAE version 5.0.
Pharmacokinetics (PK) of palazestrant when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2), everolimus (Treatment Group 3), or atirmociclib (Treatment Group 4) .
Time frame: Every 28 days
To assess the PK of palazestrant (and potential metabolites) in combination with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), everolimus (Treatment Group 3), or atirmociclib (Treatment Group 4). Plasma levels of palazestrant will be assessed at predefined intervals to establish PK parameters (including: Cmax, Cmin, Tmax, AUC, and t1⁄2 as data permit) and palazestrant trough concentration at steady state).
3 secondary outcomes
Preliminarily assess the anti-tumor activity Overall Response Rate of palazestrant when administered with ribociclib, alpelisib, everolimus, or atirmociclib as assessed by the investigator using RECIST v1.1.
Time frame: Up to 1 year
Evaluate clinical benefit rate (CBR) of palazestrant when administered with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), or everolimus (Treatment Group 3), or atirmociclib (Treatment Group 4).
Time frame: Up to 1 year
Evaluate duration of response (DoR) of palazestrant when administered with ribociclib (Treatment Group 1), alpelisib (Treatment Group 2), everolimus (Treatment Group 3), or atirmociclib (Treatment Group 4).
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Kenneth Caldwell, MD study director
Olema Pharmaceuticals, Inc.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Palazestrant, Ribociclib and Alpelisib in people with Metastatic Breast Cancer and ER-positive Breast Cancer, run by Olema Pharmaceuticals, Inc. at 16 sites in 2 countries.
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 14 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Australia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Dose Limiting Toxicities (DLTs) (time frame: The first 28 days of treatment). The study lists 3 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 15 Sep 2026.