Metastatic or Locally-advanced Unresectable Breast CancerPhase 1NCT01870505
BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer
A Phase 1 study testing BYL719, Letrozole and Exemestane in people with Metastatic or Locally-advanced Unresectable Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test the safety of a drug called BYL719 at different dose levels. The investigators want to find out what effects, good and/or bad, BYL719 has on the patient and breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic or Locally-advanced Unresectable Breast Cancer
- What is being tested?
- BYL719, Letrozole and Exemestane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 28 Feb 2022
- Phase
- Phase 1
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women age ≥ 18 years
- Willing and able to comply with scheduled visits, treatment plan and laboratory tests
- Willing and able to consent for biopsy of locally-advanced or metastatic breast cancer prior to treatment
- Metastatic or locally-advanced unresectable breast cancer (includes metastatic or locally-advanced unresectable breast cancer which is diagnosed while on adjuvant letrozole or exemestane)
- Histologically documented HR+ breast cancer in either the primary or metastatic setting, as defined by ER or PR ≥ 1%; results from the local lab are acceptable. Eligibility will not be affected by HER2 status.
- The most recent treatment prior to enrollment must be one of the following (duration of treatment ≥2 weeks), and must have been adequately tolerated according the treating physician's judgment:
Show all 34Show fewer
- Letrozole
- Exemestane
- Exemestane + everolimus (everolimus must be discontinued for ≥ 3 weeks prior to starting study treatment)
- Letrozole or exemestane in combination with an experimental agent(s) on a clinical trial, provided that the experimental agent(s) is not a PI3K inhibitor or AKT inhibitor (experimental agent(s) must be discontinued for ≥ 3 weeks prior to starting study treatment)
- Any number of prior endocrine therapies (including tamoxifen, fulvestrant and/or aromatase inhibitors in either the adjuvant or metastatic setting) and any number of prior chemotherapy regimens. Anti-cancer systemic therapy, such as chemotherapy or biologics or endocrine therapy, other than the AI, must be discontinued for ≥ 3 weeks prior to starting study treatment.
- For the dose-finding phase, patients must also have stable disease OR progression of disease on the most recent treatment. For the expansion phase, patients must have progression of disease on the most recent treatment. Progression of disease is defined as new or worsening disease on objective imaging. Progression of disease includes recurrence diagnosed while on adjuvant letrozole or exemestane.
- Postmenopausal women, as defined by one of the following (estradiol assay cutoff takes into account that the patient is on aromatase inhibitor therapy):
- Age ≥ 55 years and one year or more of amenorrhea
- Age < 55 years and one year or more of amenorrhea, with an estradiol assay within the post-menopausal range
- Age < 55 years with prior hysterectomy but intact ovaries, with an estradiol assay within the post-menopausal range
- Surgical menopause with bilateral oophorectomy
- Ovarian suppression with a LH-RH agonist, with an estradiol assay within the post-menopausal range at baseline and periodically on-study Measurable or non-measurable disease per RECIST criteria v1.1
- ECOG performance status 0-1
- Adequate organ function, as defined by all of the following:
- Hematologic parameters:
- Absolute neutrophil count (ANC) ≥ 1500/μl (without growth factor support)
- Platelets ≥ 100,000/μl (no transfusion allowed within 2 weeks)
- Hemoglobin ≥ 9.0 g/dl (may be reached by transfusion)
- Liver function:
- Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) unless attributable to Gilbert's syndrome
- AST ≤ 2.5 x ULN, or ≤ 5 x ULN if liver metastases are present
- ALT ≤ 2.5 x ULN, or ≤ 5 x ULN if liver metastases are present
- Kidney function:
- Creatinine ≤ 1.5 ULN
- Endocrine function:
- Fasting plasma glucose <140 mg/dl (may be on antiglycemic agents other than insulin). Fasting glucose measurement must be obtained at least 8 hours after the most recent caloric intake.
- Ability to swallow oral medication
- Willing to discontinue all herbal preparations / medications at least 7 days prior to the first dose of study drug and throughout the study. These include, but not limited to,St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng.
Who cannot join
- Pregnant patients or women who are breast-feeding (patients must be postmenopausal, see Section 6.1.9)
- Patients with central nervous system (CNS) involvement may participate if:
- Clinically stable with respect to the CNS tumor at the time of screening and >4 weeks from prior therapy completion (including radiation and/or surgery) to the start of study treatment
- Not receiving steroid therapy
- Not receiving enzyme inducing anti-epileptic medications that were started for brain metastases (these include carbamazepine, phenytoin, phenobarbital, primidone, oxcarbazepine, topiramate, and vigabatrin) Prior PI3K inhibitor or AKT inhibitor (patients previously treated with everolimus are eligible, see rationale in Section 3.6)
- History of toxicity to the most recent AI (letrozole or exemestane) that warrants cessation of the AI
Show all 18Show fewer
- Patients who have received radiotherapy ≤ 2 weeks prior to starting study treatment
- Patients who have undergone major surgery ≤ 4 weeks prior to starting study treatment, who have not recovered from side effects of such procedure
- Uncontrolled diabetes (as defined by fasting glucose ≥ 140mg/dL) and/or insulin-dependent diabetes. Fasting glucose measurement must be obtained at least 8 hours after the most recent caloric intake. Patients currently requiring the use of antiglycemic agents (other than insulin) may be enrolled if fasting glucose <140mg/dL.
- Current need for chronic corticosteroid therapy (≥10mg of prednisone daily or an equivalent dose of other corticosteroid), or patients who have received systemic corticosteroids ≤ 2 weeks prior to starting study drug
- Current therapeutic anticoagulation with warfarin (or coumarin derivatives) Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment
- Clinically significant cardiac disease or impaired cardiac function, such as:
- Congestive heart failure requiring treatment (e.g., New York Heart Association Class II, III or IV) Acute coronary syndromes < 3 months prior to screening (including myocardial infarction, unstable angina, coronary artery bypass graft, coronary angioplasty, or stenting)
- Uncontrolled arterial hypertension defined by blood pressure > 140/100 mm Hg at rest (average of 3 consecutive readings)
- History or current evidence of unstable, clinically significant cardiac arrhythmias or patients that require medications with a narrow therapeutic window, atrial fibrillation and/or conduction abnormality, e.g. congenital long QT syndrome, high-Grade/complete AV-blockage
- Corrected QT interval (QTc) > 480 msec on screening ECG Patients who are currently receiving medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes (TdP) and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug treatment (see Section 9.6.3 and Appendix F)
- Impaired gastrointestinal function or poorly controlled gastrointestinal disease that may significantly alter the absorption of oral BYL719 (e.g. Crohn's disease, ulcerative colitis, malabsorption syndrome, small bowel resection, uncontrolled nausea or vomiting, or grade ≥ 3 diarrhea of any etiology) based on treating physician assessment
- Patients may not have a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase I Trial of BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer
The purpose of this study is to test the safety of a drug called BYL719 at different dose levels. The investigators want to find out what effects, good and/or bad, BYL719 has on the patient and breast cancer. BYL719 will be given with either letrozole or exemestane to patients with HR+ locally-advanced or metastatic breast cancer. When the recommended phase II dose of BYL719 in combination with letrozole or exemestane has been determined in the dose-finding phase, an additional 10 patients will be enrolled onto each arm in an expansion phase of the study. The purpose of the expansion phase is to further define the safety and feasibility of BYL719 in combination with letrozole or exemestane at the recommended phase II dose, and to estimate efficacy.
- Being tested
- BYL719, Letrozole, Exemestane
- Keywords
- BYL719, Letrozole, Exemestane, 13-027
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BYL719Drug
LetrozoleDrug
ExemestaneDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A: BYL719 plus Letrozole | Experimental | For both the dose-finding phase and the expansion phase, patients may have stable or progressive disease on letrozole, and BYL719 will be added. A treatment cycle will consist of 28 days. Treatment doses for each AI will be fixed at the established dose. Patients will continue on treatment until progression of disease or unacceptable toxicity. The initial scan interval to assess disease status will be every two cycles (8 weeks) for the first four cycles (16 weeks), and then every 3rd cycle (12 weeks) thereafter. Receives: Drug: BYL719; Drug: Letrozole |
| Arm B: BYL719 plus Exemestane | Experimental | For both the dose-finding phase and the expansion phase, patients may have stable or progressive disease on Exemestane, and BYL719 will be added. A treatment cycle will consist of 28 days. Treatment doses for each AI will be fixed at the established dose. Patients will continue on treatment until progression of disease or unacceptable toxicity. The initial scan interval to assess disease status will be every two cycles (8 weeks) for the first four cycles (16 weeks), and then every 3rd cycle (12 weeks) thereafter. Receives: Drug: BYL719; Drug: Exemestane |
| Arm C: BYL719 plus Letrozole | Experimental | For both the dose-finding and expansion phases of Arms C and D, patients may have stable or progressive disease on letrozole or exemestane, and BYL719 will be added.Letrozole 2.5mg orally once daily with BYL719 given on days 1-7 and 15-21 of a 28 day cycle. The starting dose of BYL719 in Arms C will be 250mg daily. Patients who are on study under Amendment 13, the scan interval will become every 4th cycle (16 weeks ±4 weeks) from their last scan. Receives: Drug: BYL719; Drug: Letrozole |
| Arm D: BYL719 plus Exemestane | Experimental | For both the dose-finding and expansion phases of Arms C and D, patients may have stable or progressive disease on letrozole or exemestane, and BYL719 will be added. Exemestane 25mg orally once daily BYL719 Days 1-5, 8-12, 15-19, 22-26 of 28 day cycle. For Arm D, the established dose is 350mg for BYL719, 10 patients will be assigned to the corresponding arm in the expansion phase of the study. Patients who are on study under Amendment 13, the scan interval will become every 4th cycle (16 weeks ±4 weeks) from their last scan. Receives: Drug: BYL719; Drug: Exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II Dose of BYL719/Alpelisib (Arm A and Arm B)
Participants started BYL719 dose of 300mg daily for cohort 0. Consecutive cohorts were administered increasing or decreasing dose levels of BYL719. All participants within a cohort will be observed for toxicity for one cycle (28 days) prior to entering additional patients.
Measured: 28 days (1 Cycle)
Phase II Dose of BYL719 (Arm C and Arm D)
Participants started BYL719 dose of 250 daily for cohort 0. Consecutive cohorts were administered increasing or decreasing dose levels of BYL719.
Measured: 28 days (1 cycle)
Secondary outcomes (3)
Number of Participants Evaluated for Safety and Tolerability of BYL719 (Arm A, B, C and D)
Toxicity will be tabulated using the NCI Common Toxicity Criteria (CTCAE), version 4.0. A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as at least possibly related to the study medication, meeting any of the criteria listed in the table below, and occurring during Cycle 1 (≤ 28 days following the first dose of BYL719, including those in which the event started in Cycle 1 and the confirmation of the DLT occurs in a subsequent cycle).
Measured: 28 days (1 cycle)
Efficacy of BYL719 (Arm A, Arm B, Arm C and Arm D)
Overall response rate
Measured: 2 years
Median Time to Treatment Failure/TTF
Time to Treatment Failure/TTF defined as the time from on-study date to off-study date for any reason
Measured: through study completion, an average of 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startMay 2013
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic or Locally-advanced Unresectable Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Sarat Chandarlapaty, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870505
- Sponsor's protocol ID
- 13-027
- Status last verified
- Mar 2022
- First submitted
- 3 Jun 2013
- Last updated
- 9 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Razavi P, Dickler MN, Shah PD, Toy W, Brown DN, Won HH, Li BT, Shen R, Vasan N, Modi S, Jhaveri K, Caravella BA, Patil S, Selenica P, Zamora S, Cowan AM, Comen E, Singh A, Covey A, Berger MF, Hudis CA, Norton L, Nagy RJ, Odegaard JI, Lanman RB, Solit DB, Robson ME, Lacouture ME, Brogi E, Reis-Filho JS, Moynahan ME, Scaltriti M, Chandarlapaty S. Alterations in PTEN and ESR1 promote clinical resistance to alpelisib plus aromatase inhibitors. Nat Cancer. 2020 Apr;1(4):382-393. doi: 10.1038/s43018-020-0047-1. Epub 2020 Mar 23.
PubMed 32864625
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01870505
- Acronym / sponsor ID
- 13-027
- Keywords
- BYL719, Letrozole, Exemestane, 13-027
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- May 2013 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Posted 9 Dec 2024
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 test the safety of a drug called BYL719 at different dose levels. The investigators want to find out what effects, good and/or bad, BYL719 has on the patient and breast cancer. BYL719 will be given with either letrozole or exemestane to patients with HR+ locally-advanced or metastatic breast cancer. When the recommended phase II dose of BYL719 in combination with letrozole or exemestane has been determined in the dose-finding phase, an additional 10 patients will be enrolled onto each arm in an expansion phase of the study. The purpose of the expansion phase is to further define the safety and feasibility of BYL719 in combination with letrozole or exemestane at the recommended phase II dose, and to estimate efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A: BYL719 plus Letrozole | Experimental | Drug: BYL719, Drug: LetrozoleFor both the dose-finding phase and the expansion phase, patients may have stable or progressive disease on letrozole, and BYL719 will be added. A treatment cycle will consist of 28 days. Treatment doses for each AI will be fixed at the established dose. Patients will continue on treatment until progression of disease or unacceptable toxicity. The initial scan interval to assess disease status will be every two cycles (8 weeks) for the first four cycles (16 weeks), and then every 3rd cycle (12 weeks) thereafter. |
| Arm B: BYL719 plus Exemestane | Experimental | Drug: BYL719, Drug: ExemestaneFor both the dose-finding phase and the expansion phase, patients may have stable or progressive disease on Exemestane, and BYL719 will be added. A treatment cycle will consist of 28 days. Treatment doses for each AI will be fixed at the established dose. Patients will continue on treatment until progression of disease or unacceptable toxicity. The initial scan interval to assess disease status will be every two cycles (8 weeks) for the first four cycles (16 weeks), and then every 3rd cycle (12 weeks) thereafter. |
| Arm C: BYL719 plus Letrozole | Experimental | Drug: BYL719, Drug: LetrozoleFor both the dose-finding and expansion phases of Arms C and D, patients may have stable or progressive disease on letrozole or exemestane, and BYL719 will be added.Letrozole 2.5mg orally once daily with BYL719 given on days 1-7 and 15-21 of a 28 day cycle. The starting dose of BYL719 in Arms C will be 250mg daily. Patients who are on study under Amendment 13, the scan interval will become every 4th cycle (16 weeks ±4 weeks) from their last scan. |
| Arm D: BYL719 plus Exemestane | Experimental | Drug: BYL719, Drug: ExemestaneFor both the dose-finding and expansion phases of Arms C and D, patients may have stable or progressive disease on letrozole or exemestane, and BYL719 will be added. Exemestane 25mg orally once daily BYL719 Days 1-5, 8-12, 15-19, 22-26 of 28 day cycle. For Arm D, the established dose is 350mg for BYL719, 10 patients will be assigned to the corresponding arm in the expansion phase of the study. Patients who are on study under Amendment 13, the scan interval will become every 4th cycle (16 weeks ±4 weeks) from their last scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Women age ≥ 18 years
- Willing and able to comply with scheduled visits, treatment plan and laboratory tests
- Willing and able to consent for biopsy of locally-advanced or metastatic breast cancer prior to treatment
- Metastatic or locally-advanced unresectable breast cancer (includes metastatic or locally-advanced unresectable breast cancer which is diagnosed while on adjuvant letrozole or exemestane)
- Histologically documented HR+ breast cancer in either the primary or metastatic setting, as defined by ER or PR ≥ 1%; results from the local lab are acceptable. Eligibility will not be affected by HER2 status.
Key exclusion criteria (18 listed)
- Pregnant patients or women who are breast-feeding (patients must be postmenopausal, see Section 6.1.9)
- Clinically stable with respect to the CNS tumor at the time of screening and >4 weeks from prior therapy completion (including radiation and/or surgery) to the start of study treatment
- Not receiving steroid therapy
- Not receiving enzyme inducing anti-epileptic medications that were started for brain metastases (these include carbamazepine, phenytoin, phenobarbital, primidone, oxcarbazepine, topiramate, and vigabatrin) Prior PI3K inhibitor or AKT inhibitor (patients previously treated with everolimus are eligible, see rationale in Section 3.6)
- History of toxicity to the most recent AI (letrozole or exemestane) that warrants cessation of the AI
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 |
|---|---|---|
| BYL719 | Drug | Arm A: BYL719 plus Letrozole, Arm B: BYL719 plus Exemestane, Arm C: BYL719 plus Letrozole, Arm D: BYL719 plus Exemestane |
| Letrozole | Drug | Arm A: BYL719 plus Letrozole, Arm C: BYL719 plus Letrozole |
| Exemestane | Drug | Arm B: BYL719 plus Exemestane, Arm D: BYL719 plus Exemestane |
Primary outcome
Phase II Dose of BYL719/Alpelisib (Arm A and Arm B)
Time frame: 28 days (1 Cycle)
Participants started BYL719 dose of 300mg daily for cohort 0. Consecutive cohorts were administered increasing or decreasing dose levels of BYL719. All participants within a cohort will be observed for toxicity for one cycle (28 days) prior to entering additional patients.
Phase II Dose of BYL719 (Arm C and Arm D)
Time frame: 28 days (1 cycle)
Participants started BYL719 dose of 250 daily for cohort 0. Consecutive cohorts were administered increasing or decreasing dose levels of BYL719.
3 secondary outcomes
Number of Participants Evaluated for Safety and Tolerability of BYL719 (Arm A, B, C and D)
Time frame: 28 days (1 cycle)
Efficacy of BYL719 (Arm A, Arm B, Arm C and Arm D)
Time frame: 2 years
Median Time to Treatment Failure/TTF
Time frame: through study completion, an average of 3.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32864625Razavi P, Dickler MN, Shah PD, Toy W, Brown DN, Won HH, Li BT, Shen R, Vasan N, Modi S, Jhaveri K, Caravella BA, Patil S, Selenica P, Zamora S, Cowan AM, Comen E, Singh A, Covey A, Berger MF, Hudis CA, Norton L, Nagy RJ, Odegaard JI, Lanman RB, Solit DB, Robson ME, Lacouture ME, Brogi E, Reis-Filho JS, Moynahan ME, Scaltriti M, Chandarlapaty S. Alterations in PTEN and ESR1 promote clinical resistance to alpelisib plus aromatase inhibitors. Nat Cancer. 2020 Apr;1(4):382-393. doi: 10.1038/s43018-020-0047-1. Epub 2020 Mar 23.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Metastatic or Locally-advanced Unresectable Breast Cancer
RecruitingPhase 2/3
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
HER2-positive Breast Cancer
RecruitingPhase 3
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Breast Neoplasms
RecruitingPhase 1
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 1/2
A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors
Locally Advanced or Metastatic Malignant Solid Tumors
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.
Sarat Chandarlapaty, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BYL719, Letrozole and Exemestane in people with Metastatic or Locally-advanced Unresectable Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site 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 34 inclusion and 18 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 9 Dec 2024. 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 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 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?
Yes. Results are posted in the registry (first posted 9 Dec 2024). 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?
Phase II Dose of BYL719/Alpelisib (Arm A and Arm B) (time frame: 28 days (1 Cycle)). 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?
On the ClinicalTrials.gov record for NCT01870505, which also lists 1 linked publication.
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 9 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.