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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01617668




Registration number
NCT01617668
Ethics application status
Date submitted
30/05/2012
Date registered
12/06/2012
Date last updated
17/10/2016

Titles & IDs
Public title
A Randomized, Phase 2, Neoadjuvant Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer
Scientific title
A Phase II Multi-center, Open-label, Neoadjuvant, Randomized Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer
Secondary ID [1] 0 0
2012-000677-23
Secondary ID [2] 0 0
CLCL161A2201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LCL161
Treatment: Drugs - paclitaxel

Experimental: Paclitaxel with LCL161 - Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LECL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.

Active comparator: Paclitaxel without LCL161 - Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.


Treatment: Drugs: LCL161
LCL161 was available as 300 mg, tablets, which was supplied in child-resistant bottles.

Treatment: Drugs: paclitaxel
Commercially available paclitaxel was sourced locally by each study site. Generic paclitaxel could be used for study treatment.

iv 80mg/m2
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pathological Complete Response (pCR) Rate in Breast After 12 Weeks of Therapy
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Number of Participants With Pathological Complete Response (pCR) in Breast After 12 Weeks of Therapy
Timepoint [2] 0 0
12 weeks
Primary outcome [3] 0 0
Difference in pCR Rates Between Treatment Arms
Timepoint [3] 0 0
12 weeks
Secondary outcome [1] 0 0
Posterior Distribution of Difference of pCR Rates After Treatment With LCL161 + Paclitaxel Between Patients With Gene Expression Positive and Negative Tumors
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Posterior Distribution of Difference in pCR Rates After Treatment With Paclitaxel Only Between Gene Expression Positive and Negative Tumors
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
pCR Rate in Breast After 12 Weeks of Therapy With Single Agent LCL161 and LCL161 + Paclitaxel, Regardless of Gene Signature Status
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
pCR Rate in Breast, Regional Nodes and Axilla
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Rates of Breast Conserving Surgery and Mastectomy - Assessed by Percentage of Patients Who Underwent Breast Conserving Surgery, Masectomy and no Surgery
Timepoint [5] 0 0
16 weeks
Secondary outcome [6] 0 0
Caspase 3 Activation in Tumor by Immunohistochemistry (IHC) - EAS1
Timepoint [6] 0 0
Baseline, Post-baeline at Cycle 1, Day 2 (C1D2) or Cycle 1, Day 9 (C1D9)
Secondary outcome [7] 0 0
Caspase 3 Activation in Tumor by Immunohistochemistry (IHC) - EAS2
Timepoint [7] 0 0
Baseline, Post-baeline at Cycle 1, Day 2 or Cycle 1, Day 9
Secondary outcome [8] 0 0
Pharmacokinetics (PK) Parameters of LCL161 Only for Cmax
Timepoint [8] 0 0
cycle 1 day 1, cycle 4 day 15
Secondary outcome [9] 0 0
Pharmacokinetics (PK) Parameters of LCL161 Only for Tmax
Timepoint [9] 0 0
cycle 1 day 1, cycle 4 day 15
Secondary outcome [10] 0 0
Pharmacokinetics (PK) Parameters of LCL161 Only for AUClast
Timepoint [10] 0 0
cycle 1 day 1, cycle 4 day 15

Eligibility
Key inclusion criteria
* Histologically confirmed diagnosis of invasive triple negative breast cancer
* Known status for the LCL161 predictive gene expression signature as determined during molecular pre-screening
* Candidates for mastectomy or breast-conserving surgery
* Primary tumor of greater than 20 mm and less than or equal to 50 mm diameter measured by imaging (previous Amendment #3 was tumor size greater than 10 mm)
* Regional nodes N0-N2
* Absence of distant metastatic disease
* ECOG performance status 0-1
* Adequate bone marrow function
* Adequate liver function and serum transaminases
* Adequate renal function
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Bilateral or inflammatory breast cancer (bilateral mammography is required during Screening/baseline); locally recurrent breast cancer
* Patients currently receiving systemic therapy for any other malignancy, or having received systemic therapy for a malignancy in the preceding 3 months
* Uncontrolled cardiac disease
* Patients who are currently receiving chronic treatment (>3 months) with corticosteroids at a dose = 10 mg of prednisone (or its glucocorticoid equivalent) per day (inhaled and topical steroids are allowed), or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug
* Impaired GI function that may affect the absorption of LCL161
* Pregnant or breast feeding (lactating) women
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 180 days after study treatment
* Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
209
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Wisconsin
Country [11] 0 0
Brazil
State/province [11] 0 0
SC
Country [12] 0 0
Brazil
State/province [12] 0 0
SP
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Brno
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Olomouc
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Düsseldorf
Country [17] 0 0
Germany
State/province [17] 0 0
Erlangen
Country [18] 0 0
Germany
State/province [18] 0 0
Essen
Country [19] 0 0
Germany
State/province [19] 0 0
Frankfurt
Country [20] 0 0
Germany
State/province [20] 0 0
Freiburg
Country [21] 0 0
Germany
State/province [21] 0 0
Heidelberg
Country [22] 0 0
Germany
State/province [22] 0 0
Kiel
Country [23] 0 0
Germany
State/province [23] 0 0
Lubeck
Country [24] 0 0
Germany
State/province [24] 0 0
München
Country [25] 0 0
Ireland
State/province [25] 0 0
Dublin 4
Country [26] 0 0
Ireland
State/province [26] 0 0
Dublin
Country [27] 0 0
Italy
State/province [27] 0 0
PD
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Korea
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Saint Petersburg
Country [30] 0 0
Russian Federation
State/province [30] 0 0
St. Petersburg
Country [31] 0 0
Spain
State/province [31] 0 0
Andalucia
Country [32] 0 0
Spain
State/province [32] 0 0
Catalunya
Country [33] 0 0
Spain
State/province [33] 0 0
Comunidad Valenciana
Country [34] 0 0
Spain
State/province [34] 0 0
Galicia
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taiwan, ROC
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taoyuan/ Taiwan ROC
Country [38] 0 0
Taiwan
State/province [38] 0 0
Taipei
Country [39] 0 0
United Kingdom
State/province [39] 0 0
East Sussex
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Surrey
Country [41] 0 0
United Kingdom
State/province [41] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01617668