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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: alpelisib; Drug: buparlisib; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 340
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: BYL719 Placebo, BKM120 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Mutant Cohort	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.	After 24 weeks of treatment
Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Wild-type Cohort	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.	After 24 weeks of treatment
Objective Response Rate Per Investigator Assessment According to RECIST 1.1 for Alpelisib vs. Placebo - PIK3CA Mutant Cohort	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.	After 24 weeks of treatment
Objective Response Rate According to RECIST 1.1 Per Investigator Assessment for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort	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.	After 24 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	pCR and Objective response rate according to RECIST 1.1 per investigator assessment after 24 weeks of treatment	After 24 weeks of treatment
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	pCR and Objective response rate according to RECIST 1.1 per investigator assessment after 24 weeks of treatment	After 24 weeks of treatment
Rate of Breast Conserving Surgery for Alpelisib vs. Placebo - PIK3CA Mutant Cohort	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.	After 24 weeks of treatment
Rate of Breast Conserving Surgery for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort	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.	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	Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Responders as Per pCR	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	Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Non-responders as Per pCR.	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	Association between pCR and changes in Ki67 from baseline for alpelisib vs. placebo - PIK3CA wild-type cohort: responders as per pCR	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	Association between pCR and changes in Ki67 from baseline for alpelisib vs. placebo - PIK3CA wild-type cohort: non-responders as per pCR	Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)
Preoperative Endocrine Prognostic Index (PEPI) Response as Per Central Assessment for Alpelisib vs. Placebo - PIK3CA Mutant Cohort	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.	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	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.	At the time of surgery (expected after 24 weeks of treatment)
Alpelisib PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1	Summary of primary PK parameters for alpelisib plasma concentration	0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days)
Alpelisib PK Parameter: Cmax at Cycle 1 Day 1	Summary of primary PK parameters for alpelisib plasma concentration	Cycle 1 Day 1 (each cycle is 28 days)
Alpelisib and PK Parameter: Tmax at Cycle 1 Day 1	Summary of primary PK parameters for alpelisib plasma concentration	Cycle 1 Day 1 (each cycle is 28 days)
Alpelisib PK Parameters: AUC0-24, AUClast at Cycle 4 Day 1	Summary of primary PK parameters for alpelisib plasma concentration	0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days)
Alpelisib PK Parameter: Cmax at Cycle 4 Day 1	Summary of primary PK parameters for alpelisib plasma concentration	Cycle 4 Day 1 (each cycle is 28 days)
Alpelisib PK Parameter: Tmax at Cycle 4 Day 1	Summary of primary PK parameters for alpelisib plasma concentration	Cycle 4 Day 1 (each cycle is 28 days)
Letrozole and PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1	Summary of primary PK parameters for Letrozole plasma concentration	0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days)
Letrozole PK Parameter: Cmax at Cycle 1 Day 1	Summary of primary PK parameters for letrozole plasma concentration	Cycle 1 Day 1 (each cycle is 28 days)
Letrozole PK Parameter: Tmax at Cycle 1 Day 1	Summary of primary PK parameters for letrozole plasma concentration	Cycle 1 Day 1 (each cycle is 28 days)
Letrozole PK Parameters: AUC0-24, AUClast at Cycle 4 Day 1	Summary of primary PK parameters for Letrozole plasma concentration	0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days)
Letrozole PK Parameter: Cmax at Cycle 4 Day 1	Summary of primary PK parameters for letrozole plasma concentration	Cycle 4 Day 1 (each cycle is 28 days)
Letrozole PK Parameter: Tmax at Cycle 4 Day 1	Summary of primary PK parameters for letrozole plasma concentration	Cycle 4 Day 1 (each cycle is 28 days)
Buparlisib PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1	Summary of primary PK parameters for Buparlisib plasma concentration	0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days)
Buparlisib PK Parameter: Cmax at Cycle 1 Day 1	Summary of primary PK parameters for buparlisib plasma concentration	Cycle 1 Day 1 (each cycle is 28 days)
Buparlisib PK Parameter: Tmax at Cycle 1 Day 1	Summary of primary PK parameters for buparlisib plasma concentration	Cycle 1 Day 1 (each cycle is 28 days)
Buparlisib PK Parameter: AUClast at Cycle 4 Day 1	Summary of primary PK parameters for Buparlisib plasma concentration	0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days)
Buparlisb PK Parameter: Cmax at Cycle 4 Day 1	Summary of primary PK parameters for buparlisib plasma concentration	Cycle 4 Day 1 (each cycle is 28 days)
Buparlisib PK Parameter: Tmax at Cycle 4 Day 1	Summary of primary PK parameters for buparlisib plasma concentration	Cycle 4 Day 1 (each cycle is 28 days)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Mayer IA, Prat A, Egle D, Blau S, Fidalgo JAP, Gnant M, Fasching PA, Colleoni M, Wolff AC, Winer EP, Singer CF, Hurvitz S, Estevez LG, van Dam PA, Kummel S, Mundhenke C, Holmes F, Babbar N, Charbonnier L, Diaz-Padilla I, Vogl FD, Sellami D, Arteaga CL. A Phase II Randomized Study of Neoadjuvant Letrozole Plus Alpelisib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer (NEO-ORB). Clin Cancer Res. 2019 May 15;25(10):2975-2987. doi: 10.1158/1078-0432.CCR-18-3160. Epub 2019 Feb 5.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 11, 2014
• Primary Completion (ACTUAL): July 7, 2017
• Study Completion (ACTUAL): July 8, 2017

Study Registration Dates

• First Submitted: August 13, 2013
• First Submitted That Met QC Criteria: August 13, 2013
• First Posted (ESTIMATE): August 15, 2013

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Breast Cancer; neoadjuvant; HER2 negative; BYL719; hormone receptor-positive; BKM120; alpelisib; Objective Response Rate; buparlisib; Pathological Complete Response
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CBYL719A2201; 2013-001862-41 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No