Clinical Trials List
Protocol NumberCBYL719C2301
NCT Number(ClinicalTrials.gov Identfier)NCT02437318
2015-10-01 - 2020-04-30
Phase III
Terminated3
ICD-10C50
Malignant neoplasm of breast
SOLAR-1: A phase III randomized double-blind, placebo controlled study of alpelisib in combination with fulvestrant for men and postmenopausal women with hormone receptor positive, HER2-negative advanced breast cancer which progressed on or after aromatase inhibitor (AI) treatment
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 金光亮 無
- Yi-Fang Tsai 無
- Chun-Yu Liu 無
- Ta-Chung Chao 無
- 邱仁輝 無
- Jane Wang 無
The Actual Total Number of Participants Enrolled
3 Stop recruiting
Audit
None
Co-Principal Investigator
- Yu-Li Su 無
- 劉建廷 無
- 吳佳哲 無
- 吳世重 無
- Meng-Jer Hsieh 無
- Tai-Jan Chiu 無
- 藍叡 無
- 陳彥仰 無
- 陳彥豪 無
- 李易濰 無
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- MING-YANG WANG 無
- 林季宏 Division of Hematology & Oncology
- JHE-CYUAN GUO 無
- Wei-Wu Chen Division of Hematology & Oncology
- 張端瑩 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
hormone receptor positive, HER2-negative advanced breast cancer
Objectives
The primary objective is to determine whether treatment with alpelisib in combination with fulvestrant prolongs PFS compared to treatment with placebo in combination with fulvestrant based on local radiological assessment for each of the following cohorts
i) patients with PIK3CA mutant status
ii) patients with PIK3CA non-mutant status
The key secondary objective is to determine whether treatment with alpelisib in combination with fulvestrant prolongs overall survival (OS) compared to treatment with placebo in combination with fulvestrant for each of the following cohorts
i) patients with PIK3CA mutant status
ii) patients with PIK3CA non-mutant status
Test Drug
BYL719/Faslodex
Active Ingredient
BYL719/fulvestrant
Dosage Form
tablet
injection
injection
Dosage
50 mg, 200 mg
250 mg/vial
250 mg/vial
Endpoints
Efficacy assessments
● CT/ MRI every 8 weeks for the first 18 months, then every 12 weeks thereafter until disease progression, death, withdrawal of consent, loss to follow-up, or subject/guardian decision
● Brain CT or MRI as clinically indicated if brain lesion at screening
● Whole body scan as clinically indicated
● Bone X-ray, CT or MRI (if bone lesion at screening) every 8 weeks for the first
18 months and then every 12 weeks thereafter
● Skin color photography (if skin lesions at screening) every 8 weeks during the first 18 months and then every 12 weeks thereafter
● CT/ MRI for any disease outside of the chest, abdomen, pelvis (if lesion identified at screening) every 8 weeks for the first 18 months and then every 12 weeks thereafter
● Survival status every 12 weeks (or earlier if required) regardless of treatment discontinuation reason
Safety assessments
● Physical examination
● ECOG performance status
● Height, weight, and vital signs
● 12 lead ECGs
● ECHO, MUGA scan
● Laboratory assessments including hematology, biochemistry, lipid panel, coagulation (via INR) and urinalysis
● CT/ MRI every 8 weeks for the first 18 months, then every 12 weeks thereafter until disease progression, death, withdrawal of consent, loss to follow-up, or subject/guardian decision
● Brain CT or MRI as clinically indicated if brain lesion at screening
● Whole body scan as clinically indicated
● Bone X-ray, CT or MRI (if bone lesion at screening) every 8 weeks for the first
18 months and then every 12 weeks thereafter
● Skin color photography (if skin lesions at screening) every 8 weeks during the first 18 months and then every 12 weeks thereafter
● CT/ MRI for any disease outside of the chest, abdomen, pelvis (if lesion identified at screening) every 8 weeks for the first 18 months and then every 12 weeks thereafter
● Survival status every 12 weeks (or earlier if required) regardless of treatment discontinuation reason
Safety assessments
● Physical examination
● ECOG performance status
● Height, weight, and vital signs
● 12 lead ECGs
● ECHO, MUGA scan
● Laboratory assessments including hematology, biochemistry, lipid panel, coagulation (via INR) and urinalysis
Inclution Criteria
Key Inclusion criteria
● Patient is man or postmenopausal woman
● Patient has adequate FFPE tumor tissue for the analysis of PIK3CA mutational status by a Novartis designated laboratory. One tumor block (preferred) or 15 to 20 slides (15 slides minimum from a surgical specimen, 20 slides minimum from a biopsy) are requested
● Patient has identified PIK3CA status (mutated or non-mutated; determined by a
Novartis designated laboratory on the FFPE sample or slides)
● Patient has advanced (loco regionally recurrent not amenable to curative therapy or metastatic) breast cancer.
Patients may be:
● relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease
● relapsed with documented evidence of progression on or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease
● relapsed with documented evidence of progression more than 12 months from completion of adjuvant endocrine therapy and then subsequently progressed with documented evidence of progression after one line of endocrine therapy for metastatic disease
● newly diagnosed advanced breast cancer, then relapsed with documented evidence of progression after one line of endocrine therapy
● Patient has recurrence or progression of disease during or after AI therapy (i.e. letrozole, anastrozole, exemestane).
● Patient has a histologically and/or cytologically confirmed diagnosis of ER+
and/or PgR+ breast cancer by local laboratory
● Patient 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
● Patient has either measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria OR if no measurable disease is present, then at least one predominantly lytic bone lesion must be present
● Patient has ECOG performance status 0 or 1
● Patient has adequate bone marrow function
● Patient is man or postmenopausal woman
● Patient has adequate FFPE tumor tissue for the analysis of PIK3CA mutational status by a Novartis designated laboratory. One tumor block (preferred) or 15 to 20 slides (15 slides minimum from a surgical specimen, 20 slides minimum from a biopsy) are requested
● Patient has identified PIK3CA status (mutated or non-mutated; determined by a
Novartis designated laboratory on the FFPE sample or slides)
● Patient has advanced (loco regionally recurrent not amenable to curative therapy or metastatic) breast cancer.
Patients may be:
● relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease
● relapsed with documented evidence of progression on or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease
● relapsed with documented evidence of progression more than 12 months from completion of adjuvant endocrine therapy and then subsequently progressed with documented evidence of progression after one line of endocrine therapy for metastatic disease
● newly diagnosed advanced breast cancer, then relapsed with documented evidence of progression after one line of endocrine therapy
● Patient has recurrence or progression of disease during or after AI therapy (i.e. letrozole, anastrozole, exemestane).
● Patient has a histologically and/or cytologically confirmed diagnosis of ER+
and/or PgR+ breast cancer by local laboratory
● Patient 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
● Patient has either measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria OR if no measurable disease is present, then at least one predominantly lytic bone lesion must be present
● Patient has ECOG performance status 0 or 1
● Patient has adequate bone marrow function
Exclusion Criteria
Key Exclusion criteria
● Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator’s best judgment
● Patient has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor
● Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer
● Patient has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to randomization, and who has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia) and/or from whom ≥ 25% of the bone marrow was irradiated
● Patients with an established diagnosis of diabetes mellitus type I or not controlled type II
● Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs
● Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, contraindicate patient participation in the clinical study
● Patient has currently documented pneumonitis
● Patient has active cardiac disease or a history of cardiac dysfunction
● Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator’s best judgment
● Patient has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor
● Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer
● Patient has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to randomization, and who has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia) and/or from whom ≥ 25% of the bone marrow was irradiated
● Patients with an established diagnosis of diabetes mellitus type I or not controlled type II
● Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs
● Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, contraindicate patient participation in the clinical study
● Patient has currently documented pneumonitis
● Patient has active cardiac disease or a history of cardiac dysfunction
The Estimated Number of Participants
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Taiwan
20 participants
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Global
560 participants
