ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01923168
Recruitment Status : Completed
First Posted : August 15, 2013
Results First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of the study was to determine whether treatment with a PI3K inhibitor plus letrozole led to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in patients with Breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: alpelisib Drug: buparlisib Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Double-blind Placebo Controlled, Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women With Hormone Receptor-positive HER2-negative Breast Cancer
Actual Study Start Date : March 11, 2014
Actual Primary Completion Date : July 7, 2017
Actual Study Completion Date : July 8, 2017

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Alpelisib + Letrozole
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
Drug: alpelisib
BYL719 + Letrozole
Other Name: BYL719

Experimental: Buparlisib + Letrozole
Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.
Drug: buparlisib
BKM120 + Letrozole
Other Name: BKM120

Placebo Comparator: Placebo + Letrozole
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
Drug: Placebo
Placebo (of BYL719 or BKM120) + Letrozole
Other Name: BYL719 Placebo, BKM120 Placebo




Primary Outcome Measures :
  1. Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Mutant Cohort [ Time Frame: After 24 weeks of treatment ]
    Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.

  2. Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Wild-type Cohort [ Time Frame: After 24 weeks of treatment ]
    Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.

  3. Objective Response Rate Per Investigator Assessment According to RECIST 1.1 for Alpelisib vs. Placebo - PIK3CA Mutant Cohort [ Time Frame: After 24 weeks of treatment ]

    Objective Response Rate (ORR) defined as the proportion of patients with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1.

    BOR was assessed per MRI or Ultrasound and defined as per RECIST 1.1 as CR for a disappearance of all non-nodal target lesions (TL)/non-target lesions (NTL) and a reduction in short axis to < 10 mm of any pathological lymph nodes assigned as TL/NTL and no new lesion; as PR if not qualifying for CR but with a decrease from baseline ≥ 30% in the sum of diameter of all TL, no progression of NTL and no new lesion.


  4. Objective Response Rate According to RECIST 1.1 Per Investigator Assessment for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort [ Time Frame: After 24 weeks of treatment ]

    Objective Response Rate (ORR) defined as the proportion of patients with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1.

    BOR was assessed per MRI or Ultrasound and defined as per RECIST 1.1 as CR for a disappearance of all non-nodal target lesions (TL)/non-target lesions (NTL) and a reduction in short axis to < 10 mm of any pathological lymph nodes assigned as TL/NTL and no new lesion; as PR if not qualifying for CR but with a decrease from baseline ≥ 30% in the sum of diameter of all TL, no progression of NTL and no new lesion.



Secondary Outcome Measures :
  1. pCR and Objective Response Rate According to RECIST 1.1 Criteria Per Investigator Assessment for Alpelisib vs. Placebo in PIK3CA Mutant Cohort Based on ctDNA [ Time Frame: After 24 weeks of treatment ]
    pCR and Objective response rate according to RECIST 1.1 per investigator assessment after 24 weeks of treatment

  2. pCR and Objective Response Rate According to RECIST 1.1 Criteria Per Investigator Assessment for Alpelisib vs. Placebo in PIK3CA Wild-type Cohort Based on ctDNA [ Time Frame: After 24 weeks of treatment ]
    pCR and Objective response rate according to RECIST 1.1 per investigator assessment after 24 weeks of treatment

  3. Rate of Breast Conserving Surgery for Alpelisib vs. Placebo - PIK3CA Mutant Cohort [ Time Frame: After 24 weeks of treatment ]
    Breast conserving surgery is defined for participants who underwent surgery and did not have a mastectomy. The row "no surgery" provides the number of patients who did not undergo surgery at all for various reasons.

  4. Rate of Breast Conserving Surgery for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort [ Time Frame: After 24 weeks of treatment ]
    Breast conserving surgery is defined as the percentage of participants with no mastectomy following completion of 24 weeks of treatment. Breast conserving surgery is defined for participants who underwent surgery and did not have a mastectomy. The row "no surgery" provides the number of patients who did not undergo surgery at all for various reasons.

  5. Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Responders as Per pCR [ Time Frame: Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment) ]
    Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Responders as Per pCR

  6. Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Non-responders as Per pCR [ Time Frame: Baseline, Cycle 1 Day 15 (each cycle is 28 days ) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment) ]
    Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Non-responders as Per pCR.

  7. Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort: Responders as Per pCR [ Time Frame: Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment) ]
    Association between pCR and changes in Ki67 from baseline for alpelisib vs. placebo - PIK3CA wild-type cohort: responders as per pCR

  8. Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort: Non-responders as Per pCR [ Time Frame: Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment) ]
    Association between pCR and changes in Ki67 from baseline for alpelisib vs. placebo - PIK3CA wild-type cohort: non-responders as per pCR

  9. Preoperative Endocrine Prognostic Index (PEPI) Response as Per Central Assessment for Alpelisib vs. Placebo - PIK3CA Mutant Cohort [ Time Frame: At the time of surgery (expected after 24 weeks of treatment) ]
    Preoperative endocrine prognostic index (PEPI) response as per central assessment for alpelisib vs. placebo - PIK3CA mutant cohort. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and ER status of the surgical specimen (Ellis et al, Contemp Clin Trials 2008). The PEPI score ranges from 0 to to 12, and a higher score means a worse outcome. PEPI response is defined as a PEPI score of 0.

  10. Preoperative Endocrine Prognostic Index (PEPI) Response as Per Central Assessment for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort [ Time Frame: At the time of surgery (expected after 24 weeks of treatment) ]
    Preoperative endocrine prognostic index (PEPI) response as per central assessment for alpelisib vs. placebo - PIK3CA wild-type cohort. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and ER status of the surgical specimen (Ellis et al, Contemp Clin Trials 2008). The PEPI score ranges from 0 to to 12, and a higher score means a worse outcome. PEPI response is defined as a PEPI score of 0.

  11. Alpelisib PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1 [ Time Frame: 0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days) ]
    Summary of primary PK parameters for alpelisib plasma concentration

  12. Alpelisib PK Parameter: Cmax at Cycle 1 Day 1 [ Time Frame: Cycle 1 Day 1 (each cycle is 28 days) ]
    Summary of primary PK parameters for alpelisib plasma concentration

  13. Alpelisib and PK Parameter: Tmax at Cycle 1 Day 1 [ Time Frame: Cycle 1 Day 1 (each cycle is 28 days) ]
    Summary of primary PK parameters for alpelisib plasma concentration

  14. Alpelisib PK Parameters: AUC0-24, AUClast at Cycle 4 Day 1 [ Time Frame: 0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days) ]
    Summary of primary PK parameters for alpelisib plasma concentration

  15. Alpelisib PK Parameter: Cmax at Cycle 4 Day 1 [ Time Frame: Cycle 4 Day 1 (each cycle is 28 days) ]
    Summary of primary PK parameters for alpelisib plasma concentration

  16. Alpelisib PK Parameter: Tmax at Cycle 4 Day 1 [ Time Frame: Cycle 4 Day 1 (each cycle is 28 days) ]
    Summary of primary PK parameters for alpelisib plasma concentration

  17. Letrozole and PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1 [ Time Frame: 0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days) ]
    Summary of primary PK parameters for Letrozole plasma concentration

  18. Letrozole PK Parameter: Cmax at Cycle 1 Day 1 [ Time Frame: Cycle 1 Day 1 (each cycle is 28 days) ]
    Summary of primary PK parameters for letrozole plasma concentration

  19. Letrozole PK Parameter: Tmax at Cycle 1 Day 1 [ Time Frame: Cycle 1 Day 1 (each cycle is 28 days) ]
    Summary of primary PK parameters for letrozole plasma concentration

  20. Letrozole PK Parameters: AUC0-24, AUClast at Cycle 4 Day 1 [ Time Frame: 0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days) ]
    Summary of primary PK parameters for Letrozole plasma concentration

  21. Letrozole PK Parameter: Cmax at Cycle 4 Day 1 [ Time Frame: Cycle 4 Day 1 (each cycle is 28 days) ]
    Summary of primary PK parameters for letrozole plasma concentration

  22. Letrozole PK Parameter: Tmax at Cycle 4 Day 1 [ Time Frame: Cycle 4 Day 1 (each cycle is 28 days) ]
    Summary of primary PK parameters for letrozole plasma concentration

  23. Buparlisib PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1 [ Time Frame: 0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days) ]
    Summary of primary PK parameters for Buparlisib plasma concentration

  24. Buparlisib PK Parameter: Cmax at Cycle 1 Day 1 [ Time Frame: Cycle 1 Day 1 (each cycle is 28 days) ]
    Summary of primary PK parameters for buparlisib plasma concentration

  25. Buparlisib PK Parameter: Tmax at Cycle 1 Day 1 [ Time Frame: Cycle 1 Day 1 (each cycle is 28 days) ]
    Summary of primary PK parameters for buparlisib plasma concentration

  26. Buparlisib PK Parameter: AUClast at Cycle 4 Day 1 [ Time Frame: 0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days) ]
    Summary of primary PK parameters for Buparlisib plasma concentration

  27. Buparlisb PK Parameter: Cmax at Cycle 4 Day 1 [ Time Frame: Cycle 4 Day 1 (each cycle is 28 days) ]
    Summary of primary PK parameters for buparlisib plasma concentration

  28. Buparlisib PK Parameter: Tmax at Cycle 4 Day 1 [ Time Frame: Cycle 4 Day 1 (each cycle is 28 days) ]
    Summary of primary PK parameters for buparlisib plasma concentration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Patient is an adult, female ≥ 18 years old at the time of informed consent
  2. Patient has a histologically and/or cytologically confirmed diagnosis of breast cancer
  3. Patient is postmenopausal.
  4. Patient has T1c-T3, any N, M0, operable breast cancer
  5. Patients must have measurable disease
  6. Patient has diagnostic biopsy available for the analysis of PIK3CA mutation and Ki67 level.
  7. Patient has estrogen-receptor and/or progesterone positive breast cancer as per local laboratory testing
  8. Patient has HER2 negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0 or 1+ as per local laboratory testing

Exclusion Criteria:

  1. Patient has locally recurrent or metastatic disease
  2. Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy, immunotherapy) or radiotherapy for current breast cancer disease before randomization.
  3. Patient with type 1 diabetes mellitus or not adequately controlled type 2 diabetes mellitus
  4. History of acute pancreatitis within 1 year of study entry
  5. Uncontrolled hypertension

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): NCT01923168


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham/ Kirklin Clinic Univ AL - PI
Birmingham, Alabama, United States, 35294-0006
United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
United States, California
Los Angeles Hematology/Oncology Medical Group Onc Dept.
Los Angeles, California, United States, 90017
University of California at Los Angeles UCLA SC
Los Angeles, California, United States, 90095
University of California San Francisco BYL719A2201 - SC
San Francisco, California, United States, 94115
United States, Georgia
Emory University School of Medicine/Winship Cancer Institute SC
Atlanta, Georgia, United States, 30322
United States, Maryland
Mercy Medical Center Medical Oncology & Hematology
Baltimore, Maryland, United States, 21202
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Johns Hopkins Med. BYL719A2201
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Dana Farber Cancer Institute BYL719A2201
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic - Rochester BYL719A2201 - SC
Rochester, Minnesota, United States, 55905
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, North Carolina
Duke University Medical Center Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
Northwest Cancer Specialists Vancouver Loc
Portland, Oregon, United States, 97210
United States, Tennessee
Vanderbilt Ingram Cancer Center Vanderbilt Health 100 Oaks
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology, P.A.
Bedford, Texas, United States, 76022
Presbyterian Hospital of Dallas TexasOncology@PresbyterianHosp
Dallas, Texas, United States, 75231
Texas Oncology Texas Oncology - Sammons
Dallas, Texas, United States, 75246
Texas Oncology Houston Memorial City SC
Houston, Texas, United States, 77024
Cancer Care Centers of South Texas HOAST CCC of So. TX- San Antonio(2)
San Antonio, Texas, United States, 78229
Cancer Therapy & Research Center UT Health Science Center InstituteForDrugDevelopment(5)
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Oncology Associates SC
Norfolk, Virginia, United States, 23502
United States, Washington
Seattle Cancer Care Alliance SC-3
Seattle, Washington, United States, 98105
Northwest Medical Specialties Dept.ofNW Med. Specialties
Tacoma, Washington, United States, 98405
Australia, New South Wales
Novartis Investigative Site
Kingswood, New South Wales, Australia, 2747
Austria
Novartis Investigative Site
Innsbruck, Tyrol, Austria, 6020
Novartis Investigative Site
Dornbirn, Vorarlberg, Austria, 6830
Novartis Investigative Site
Leoben, Austria, A-8700
Novartis Investigative Site
Rankweil, Austria, A-6830
Novartis Investigative Site
Salzburg, Austria, 5020
Novartis Investigative Site
Vienna, Austria, A-1090
Novartis Investigative Site
Villach, Austria, 9500
Novartis Investigative Site
Wien, Austria, A-1090
Belgium
Novartis Investigative Site
Edegem, Antwerpen, Belgium, 2650
Novartis Investigative Site
Leuven, Belgium, 3000
Novartis Investigative Site
Sint Niklaas, Belgium, 9100
Brazil
Novartis Investigative Site
Goiania, GO, Brazil, 74605-070
Novartis Investigative Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Novartis Investigative Site
Ribeirao Preto, SP, Brazil, 14048-900
Novartis Investigative Site
Sao Paulo, SP, Brazil, 01317-002
Novartis Investigative Site
Sao Paulo, SP, Brazil, 03102-002
Bulgaria
Novartis Investigative Site
Shumen, Bulgaria, 9700
Novartis Investigative Site
Sofia, Bulgaria, 1303
Novartis Investigative Site
Varna, Bulgaria, 9010
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H2W 1T8
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1E2
Canada
Novartis Investigative Site
Quebec, Canada, G1S 4L8
Colombia
Novartis Investigative Site
Medellin, Antioquia, Colombia
Novartis Investigative Site
Bogota, Colombia
Czechia
Novartis Investigative Site
Olomouc, CZE, Czechia, 775 20
Novartis Investigative Site
Praha, Czechia, 12808
Germany
Novartis Investigative Site
Berlin, Germany, 13125
Novartis Investigative Site
Erlangen, Germany, 91054
Novartis Investigative Site
Essen, Germany, 45136
Novartis Investigative Site
Kiel, Germany, 24105
Novartis Investigative Site
Koeln, Germany, 51067
Hong Kong
Novartis Investigative Site
Hong Kong SAR, Hong Kong
Israel
Novartis Investigative Site
Haifa, Israel, 3525408
Novartis Investigative Site
Ramat Gan, Israel, 5265601
Novartis Investigative Site
Tel Aviv, Israel, 64239
Italy
Novartis Investigative Site
Brescia, BS, Italy, 25127
Novartis Investigative Site
Cremona, CR, Italy, 26100
Novartis Investigative Site
Macerata, MC, Italy, 62100
Novartis Investigative Site
Milano, MI, Italy, 20141
Novartis Investigative Site
Napoli, Italy, 80131
Japan
Novartis Investigative Site
Nagoya-city, Aichi, Japan, 467-8602
Novartis Investigative Site
Hiroshima-city, Hiroshima, Japan, 730-8518
Novartis Investigative Site
Osaka-city, Osaka, Japan, 540-0006
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-8677
Novartis Investigative Site
Koto-ku, Tokyo, Japan, 135 8550
Novartis Investigative Site
Niigata, Japan, 951-8566
Lebanon
Novartis Investigative Site
Ashrafieh, Lebanon, 166830
Novartis Investigative Site
Beirut, Lebanon
Novartis Investigative Site
Saida, Lebanon, 652
Netherlands
Novartis Investigative Site
Delft, Netherlands, 2625 AD
Novartis Investigative Site
Den Haag, Netherlands, 2545 CH
Novartis Investigative Site
Leiden, Netherlands, 2300 RC
Novartis Investigative Site
Tilburg, Netherlands, 5022 GC
Spain
Novartis Investigative Site
Sevilla, Andalucia, Spain, 41017
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08036
Novartis Investigative Site
Hospitalet de LLobregat, Catalunya, Spain, 08907
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46010
Novartis Investigative Site
La Coruna, Galicia, Spain, 15006
Novartis Investigative Site
San Sebastián, Pais Vasco, Spain, 20014
Novartis Investigative Site
Madrid, Spain, 28007
Novartis Investigative Site
Madrid, Spain, 28040
Novartis Investigative Site
Madrid, Spain, 28050
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan  [PDF] February 7, 2017
Study Protocol  [PDF] October 18, 2016


Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01923168     History of Changes
Other Study ID Numbers: CBYL719A2201
2013-001862-41 ( EudraCT Number )
First Posted: August 15, 2013    Key Record Dates
Results First Posted: September 14, 2018
Last Update Posted: September 14, 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 ):
BYL719
alpelisib
Breast Cancer
BKM120
buparlisib
Pathological Complete Response
neoadjuvant
hormone receptor-positive
HER2 negative
Objective Response Rate

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