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Clinical Trials in Japan / NCT04524000
Active, not recruiting Phase 2

Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer

NCT04524000 · tracked via the Priya Life Science Japan tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Started
2021-01-08
Last updated
2026-09-18

Condition(s) studied

Advanced Breast Cancer

Investigational drug(s) / intervention(s)

Alpelisib →Fulvestrant →

Alpelisib: \[Part 1\] Alpelisib administered at 200 mg (DL 1), 250 mg (DL 2) or 300mg (DL 3) orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 day cycle. If DL 1 is tolerated, the alpelisib doses of 250 mg will be investigated. If DL 2 is tolerated, the alpelisib doses of 300 mg will be investigated. \[Part 2\] In the Part 2, participants will be enrolled into Cohort 2 (CDK4/6 inhibitor naive) and Cohort 3 (CDK4/6 inhibitor pre-treated) in parallel and alpelisib will be administered at the recommended dose identified in Part 1.

Fulvestrant: Fulvestrant is administered at a dose of 500 mg intramuscular on Cycle 1 Day 1, Day 15, and Day 1 of every cycle thereafter (where a cycle is 28 days).

Study summary

The purpose of this study is to assess the safety and efficacy of alpelisib plus fulvestrant in men and postmenopausal women with hormone receptor (HR) positive, human epidermal growth factor 2 (HER2)-negative, advanced breast cancer harboring a PIK3CA mutation in Japan, whose disease has progressed on or after aromatase inhibitor (AI) treatment regardless of prior CDK4/6 inhibitor use.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: * Japanese man or postmenopausal woman * Participant has adequate tumor tissue for the analysis of PIK3CA mutational status by a Novartis designated laboratory. * Participant has identified PIK3CA mutation (as determined by a Novartis designated laboratory) * Participant has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory * Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH or SISH) test is required by local laboratory testing * Participant has measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 * Participant has advanced breast cancer * Participant has ECOG performance status 0 or 1 Exclusion Criteria: * Participant with symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy per the investigator's best judgment * Participant has received prior treatment; * with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor for Cohort 1 and 3 * with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR, AKT inhibitor or CDK 4/6 inhibitor for Cohort 2 * Participant has a known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant * Participant with inflammatory breast cancer at screening * Participant is concurrently using other anti-cancer therapy * Participant has had surgery within 14 days prior to starting study drug or has not recovered from major side effects * Participant with an established diagnosis at screening of diabetes mellitus type I or not controlled type II (based on FPG and HbA1c) * Participant has currently documented pneumonitis /interstitial lung disease * History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis * Participant with unresolved osteonecrosis of the jaw * Participant has a history of severe cutaneous reactions Other protocol-defined inclusion/exclusion criteria may apply

Primary outcome measure(s)

  • [Part 1] The incidence of Dose Limiting Toxicities (DLTs) of alpelisib in combination with fulvestrant — From Cycle 1 Day 1 to Cycle 2 Day 28 (Cycle = 28 days)
    A DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 2 cycles (the first 56 days) of treatment with alpelisib in combination with fulvestrant and meets any of the criteria specified in the protocol .
  • [Part 2] Overall Response Rate (ORR) in CDK4/6 inhibitor naive participants — Up to approximately 36 months
    ORR is defined as the proportion of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on local investigator assessment per RECIST 1.1.

Trial sites (15)

FacilityCityRegionStatus
Novartis Investigative Site Nagoya Aichi-ken
Novartis Investigative Site Nagoya Aichi-ken
Novartis Investigative Site Nagoya Aichi-ken
Novartis Investigative Site Kashiwa Chiba
Novartis Investigative Site Isehara Kanagawa
Novartis Investigative Site Yokohama Kanagawa
Novartis Investigative Site Kumamoto Kumamoto
Novartis Investigative Site Sendai Miyagi
Novartis Investigative Site Osaka Osaka
Novartis Investigative Site Osaka Osaka
Novartis Investigative Site Suita Osaka
Novartis Investigative Site Bunkyo Ku Tokyo
Novartis Investigative Site Koto Ku Tokyo
Novartis Investigative Site Meguro-ku Tokyo
Novartis Investigative Site Niigata Japan

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Other trials for the same condition

Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer Recruiting
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors Recruiting
A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors Recruiting
A Study of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors Recruiting
A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04524000 on ClinicalTrials.gov ↗ ← All trials in Japan