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Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment. (SOLAR-1)

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ClinicalTrials.gov Identifier: NCT02437318
Recruitment Status : Active, not recruiting
First Posted : May 7, 2015
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Fulvestrant Drug: Alpelisib Drug: Alpelisib placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 572 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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 Treatment
Actual Study Start Date : July 23, 2015
Actual Primary Completion Date : June 12, 2018
Estimated Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant

Arm Intervention/treatment
Experimental: fulvestrant + alpelisib
Alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
Drug: Fulvestrant
Other Name: Faslodex

Drug: Alpelisib
Placebo Comparator: fulvestrant + placebo
Placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)
Drug: Fulvestrant
Other Name: Faslodex

Drug: Alpelisib placebo



Primary Outcome Measures :
  1. Progression-free survival (PFS) for patients with PIK3CA mutant status [ Time Frame: Up to approximatly 36 months ]
    PFS, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS will be assessed via a local radiology assessment according to RECIST 1.1


Secondary Outcome Measures :
  1. Overall survival (OS) for patients with PI3KCA mutant status [ Time Frame: Up to approximatly 59 months ]
    OS is defined as the time from date of randomization to date of death due to any cause.

  2. Overall response rate (ORR) [ Time Frame: Up to approximatly 36 months ]
    ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST 1.1.

  3. Time to definitive deterioration of Eastern Cooperative Oncology Group (ECOG) performance status [ Time Frame: Baseline, Up to approximatly 36 months ]
    Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

  4. Safety and tolerability of alpelisib in combination with fulvestrant [ Time Frame: Up to approximatly 37 months ]
    Safety will be determined by type, frequency and severity of adverse events per CTCAEv4.03 and type, frequency and severity of laboratory toxicities per CTCAEv4.03. Patients will be followed up for the duration of the study.

  5. Time to 10% deterioration in the global health status/Quality of Life (QOL) scale score of the EORTC QLQ-C30 [ Time Frame: Up to approximatly 36 months ]
    Composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment will be summarized

  6. Plasma concentration-time profile of alpelisib given in combinatio with fulvestrant and appropriate pharmacokinetics (PK) parameters [ Time Frame: Day 8 and Day 15 of Cycle 1, then Day 1 of Cycles 2,4, 6, 8 ]
    Assessment of any potential impact of fulvestrant on the pharmacokinetics of alpelisib by collection of sparse and trough PK samples. PK parameters includes,but not limited to, Cmin, Cmax, t1/2, AUClast for alpelisib (and any relevant metabolites) and fulvestrant

  7. PFS based on radiology assessments and using RECIST 1.1 criteria [ Time Frame: Baseline, Up to approximatly 36 months ]
    PFS in patients with PIK3CA mutant status and patients with PIK3CA non-mutant status as measured in ctDNA.

  8. Clinical benefit rate (CBR) [ Time Frame: Up to approximatly 36 months ]
    Clinical benefit rate is defined as the proportion of patients with a best overall response of CR or PR or SD or Non-CR/Non-PD lasting more than 24 weeks based on local investigator assessment.

  9. Change in the global health status/(QOL) scale score of the EORTC QLQ-C30 [ Time Frame: Baseline, Up to approximatly 36 months ]
    Composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment will be summarized

  10. Summary statistics of fulvestrant and alpelisib plasma concentrations [ Time Frame: Day 8 and Day 15 of Cycle 1, then Day 1 of Cycles 2,4, 6, 8 ]
    Assessment of any potential impact of fulvestrant on the pharmacokinetics of alpelisib by collection of sparse and trough PK samples.

  11. PFS for patients with PIK3CA non-mutant status [ Time Frame: Up to approximatly 36 months ]
    PFS based on local radiology assessments and using RECIST 1.1 criteria in the PIK3CA non-mutant cohort

  12. OS for patients with PIK3CA non-mutant status [ Time Frame: Up to approximatly 59 months ]
    OS is defined as the time from date of randomization to date of death due to any cause.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • If female, patient is postmenopausal
  • Patient has identified PIK3CA status
  • Patients may be:

    • relapsed with documented evidence of progression while on (neo) adjuvant endocrine therapy 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 (neo)adjuvant endocrine therapy and then subsequently; progressed with documented evidence of progression while on or after only one line of endocrine therapy for metastatic disease;
    • newly diagnosed advanced breast cancer, then relapsed with documented evidence of progression while on or after only 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 estrogen-receptor positive breast cancer by local laboratory and has HER2 negative breast cancer
  • Patient has either measurable disease per RECIST 1.1 criteria OR at least one predominantly lytic bone lesion must be present
  • Patient has adequate bone marrow function

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 (pre-treatment with CDK4/6 inhibitors is allowed)
  • Patient with inflammatory breast cancer at screening
  • Patients with Child pugh score B or C
  • Patients with an established diagnosis of diabetes mellitus type I or not controlled type II
  • Patient has Eastern Cooperative Oncology Group (ECOG) performance status 2 or more
  • Patient with CNS involvement unless he/she is at least 4 weeks from prior therapy completion to starting the study treatment and has stable CNS tumor at time of screening and not receiving steroids and/or enzyme inducing ant-epileptic medications for brain metastases
  • Patient has participated in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer
  • Patient has a history of acute pancreatitis within 1 year of screening or a past medical history of chronic pancreatitis
  • Patient who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease

Other protocol-defined inclusion/esclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437318


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Locations
United States, Arizona
Ironwood Cancer and Research Centers Chandler 2
Chandler, Arizona, United States, 85224
Mayo Clinic - Arizona
Scottsdale, Arizona, United States, 85259
United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
United States, California
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
Compassionate Cancer Care Medical Group CCCMG
Fountain Valley, California, United States, 92708
St. Helena Martin ONeil Cancer Center, Napa Valley SC
Helena, California, United States, 94574
Scripps Clinic SC
La Jolla, California, United States, 92037
University of California San Diego - Moores Cancer Center Onc Dept.
La Jolla, California, United States, 92093-0658
University of Calif Irvine Medical Center Uni of California, Irvine
Orange, California, United States, 92868
Kaiser Permanente - California Southern
San Diego, California, United States, 92120
University of California San Francisco
San Francisco, California, United States, 94115
United States, Florida
Florida Cancer Specialists FL Cancer Specialists
Fort Myers, Florida, United States, 33901
Florida Cancer Specialists - North SC
Saint Petersburg, Florida, United States, 33705
United States, Georgia
Cancer Treatment Centers of Americas
Newnan, Georgia, United States, 30265
United States, Illinois
Rush University Medical Center Rush Uni Medical Center
Chicago, Illinois, United States, 60612
North Shore University Health System NorthShore University
Evanston, Illinois, United States, 60201
Edward Cancer Center SC
Naperville, Illinois, United States, 60540
Orchard Healthcare Research Inc.
Skokie, Illinois, United States, 60077
United States, Indiana
Fort Wayne Medical Oncology/Hematology, Inc. Dept.of Fort Wayne Med Onc/Hem
Fort Wayne, Indiana, United States, 46815
United States, Kansas
St. Francis Health Comprehensive Cancer Center SC
Topeka, Kansas, United States, 66606-169
United States, Louisiana
Hematology and Oncology Clinic SC
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Mercy Medical Center SC-2
Baltimore, Maryland, United States, 21202
United States, Massachusetts
Massachusetts General Hospital Updated Regulatory
Boston, Massachusetts, United States, 02114
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Michigan
Detroit Clinical Research Center
Owosso, Michigan, United States, 48867
Metro Health Cancer Center
Wyoming, Michigan, United States, 49519
United States, Missouri
St. Luke's Cancer Institute SC
Kansas City, Missouri, United States, 64111
United States, Montana
St. Vincent Frontier Cancer Center
Billings, Montana, United States, 59102
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Rutgers Cancer Institute of New Jersey SC-2
New Brunswick, New Jersey, United States, 08903
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12206
United States, Ohio
Oncology & Hematology Care,Inc SC
Cincinnati, Ohio, United States, 45242
University Hospitals of Cleveland Seidman Cancer Center SC
Cleveland, Ohio, United States, 44106
United States, Oregon
Good Samaritan Regional Medical Center Good Samaritan Reg Med Ctr
Corvallis, Oregon, United States, 97330
United States, Pennsylvania
Andrew & Patel Associates,
Camp Hill, Pennsylvania, United States, 17011
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
United States, South Carolina
Charleston Hematology Oncology Association PA
Charleston, South Carolina, United States, 29414
Greenville Health System SC-2
Greenville, South Carolina, United States, 29615
United States, South Dakota
Avera Cancer SC
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Tennessee Oncology SC-3
Nashville, Tennessee, United States, 37203
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Texas Oncology PA Dallas Presbyterian Hospital SC-1
Dallas, Texas, United States, 75231
Texas Oncology P A Forth Worth -- 12th Avenue
Dallas, Texas, United States, 75251
El Paso, Texas Oncology
El Paso, Texas, United States, 79902
Texas Oncology Houston Memorial City SC
Houston, Texas, United States, 77024
Baylor College of Medicine SC
Houston, Texas, United States, 77030-3411
Methodist Richardson Cancer Center SC
Richardson, Texas, United States, 75082
Cancer Therapy & Research Center UT Health Science Center InstituteForDrugDevelopment(4)
San Antonio, Texas, United States, 78229
US Oncology, P.A.
Tyler, Texas, United States, 75702
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Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
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Virginia Cancer Specialists SC
Fairfax, Virginia, United States, 22031
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Richmond, Virginia, United States, 23230
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Vista Oncology Inc. PS
Olympia, Washington, United States, 98502
MultiCare Health System Institute for Research & Innovation SC
Tacoma, Washington, United States, 98405
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Wenatchee, Washington, United States, 98801
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Rouen Cedex 1, France, 76038
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Saint-Herblain Cédex, France, 44805
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Villejuif Cedex, France, 94805
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Muenchen, Bayern, Germany, 80335
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Aschaffenburg, Germany, 63739
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Bayreuth, Germany, 95445
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Bonn, Germany, 53111
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Essen, Germany, 45147
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Friedrichshafen, Germany, 88045
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Fulda, Germany, 36043
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Homburg, Germany, 66421
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Mainz, Germany, 55131
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Memmingen, Germany, 87700
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Potsdam, Germany, 14467
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Athens, Greece, 18547
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Hong Kong, Hong Kong
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Tuen Mun, Hong Kong
Hungary
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Budapest, Hungary, 1134
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Budapest, Hungary, H-1122
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Nyiregyhaza, Hungary, 4400
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Szeged, Hungary, 6725
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Szekszard, Hungary, 7100
India
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Vijayawada, Andhra Pradesh, India, 520002
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Indore, Madhya Pradesh, India, 452008
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Mumbai, India, 400 012
Israel
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Beer-Sheva, Israel, 8457108
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Haifa, Israel, 3525408
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Petach Tikva, Israel, 49100
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Tel Aviv, Israel, 64239
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Japan
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Nagoya, Aichi, Japan, 464-8681
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Matsuyama, Ehime, Japan, 791-0280
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Maebashi city, Gunma, Japan, 371 8511
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Sapporo-city, Hokkaido, Japan, 003-0804
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Akashi, Hyogo, Japan, 673-8558
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Kagoshima-city, Kagoshima, Japan, 892-0833
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Isehara-city, Kanagawa, Japan, 259-1193
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Yokohama-city, Kanagawa, Japan, 241-8515
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Kumamoto City, Kumamoto, Japan, 860-8556
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Osaka-city, Osaka, Japan, 540-0006
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Osaka-city, Osaka, Japan, 541-8567
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Kitaadachi-gun, Saitama, Japan, 362-0806
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Chuo-ku, Tokyo, Japan, 104-8560
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Minato-ku, Tokyo, Japan, 105-8470
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Seongnam, Gyeonggi, Korea, Republic of, 13620
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Seoul, Korea, Korea, Republic of, 05505
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Seoul, Korea, Korea, Republic of, 06351
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Seoul, Korea, Republic of, 03722
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Ashrafieh, Lebanon, 166830
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Saida, Lebanon, 652
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Morelos, Mexico, 62290
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San Luis Potosi, Mexico, 78213
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Terneuzen, Netherlands, 4535 PA
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Lima, Peru, LIMA 27
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Porto, Portugal, 4099-001
Romania
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Floresti, Cluj, Romania, 407280
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St Petersburg, Russian Federation, 199226
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St. Petersburg, Russian Federation, 197758
Spain
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Sevilla, Andalucia, Spain, 41013
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Jerez de La Frontera, Cadiz, Spain, 11407
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Badalona, Catalunya, Spain, 08916
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El Palmar, Murcia, Spain, 30120
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La Laguna, Santa Cruz De Tenerife, Spain, 38320
Novartis Investigative Site
Madrid, Spain, 28034
Novartis Investigative Site
Madrid, Spain, 28040
Novartis Investigative Site
Madrid, Spain, 28041
Novartis Investigative Site
Madrid, Spain, 28046
Novartis Investigative Site
Madrid, Spain, 28050
Novartis Investigative Site
Zaragoza, Spain, 50009
Sweden
Novartis Investigative Site
Gavle, Sweden, SE-801 87
Novartis Investigative Site
Joenkoeping, Sweden, 551 85
Novartis Investigative Site
Karlstad, Sweden, 652 30
Novartis Investigative Site
Oerebro, Sweden, 70185
Novartis Investigative Site
Vasteras, Sweden, 721 89
Taiwan
Novartis Investigative Site
Kaohsiung City, Taiwan, 83301
Novartis Investigative Site
Taipei, Taiwan, 10002
Novartis Investigative Site
Taipei, Taiwan, 11217
Thailand
Novartis Investigative Site
Bangkok, THA, Thailand, 10330
Novartis Investigative Site
Bangkok, Thailand, 10700
United Arab Emirates
Novartis Investigative Site
Al Ain Abu Dhabi, United Arab Emirates
United Kingdom
Novartis Investigative Site
Reading, Berkshire, United Kingdom, RG1 5AN
Novartis Investigative Site
Plymouth, Devon, United Kingdom, PL6 8DH
Novartis Investigative Site
Cardiff, United Kingdom, CF14 2TL
Novartis Investigative Site
Leicester, United Kingdom, LE1 5WW
Novartis Investigative Site
London, United Kingdom, SE1 9RT
Novartis Investigative Site
Manchester, United Kingdom, M20 2BX
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02437318     History of Changes
Other Study ID Numbers: CBYL719C2301
2015-000340-42 ( EudraCT Number )
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
HR+
HER2-negative
advanced breast cancer
alpelisib
fulvestrant
PI3K
Phase III
ER+
PgR+
men
postmenopausal
aromatase inhibitor
neoplasms

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Aromatase Inhibitors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Hormones
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action