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Trial record 2 of 14 for:    gdc0032

A Study of Neoadjuvant Letrozole + GDC-0032 Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Genentech, Inc.
Sponsor:
Collaborators:
SOLTI Breast Cancer Research Group
Breast International Group
Austrian Breast and Colorectal Cancer Group
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT02273973
First received: October 22, 2014
Last updated: September 9, 2015
Last verified: September 2015
  Purpose
This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 versus letrozole and placebo in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2 (HER2) untreated, Stage I-III operable breast cancer. Participants will be randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at 2.5 mg will be dosed once daily plus either GDC-0032 at 4 mg (two 2-mg tablets) or placebo on a 5 days-on/ 2 days-off schedule for a total of 16 weeks.

Condition Intervention Phase
Breast Cancer
Drug: GDC-0032
Drug: Letrozole
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Double-Blind Study of Neoadjuvant Letrozole Plus GDC-0032 Versus Letrozole Plus Placebo in Postmenopausal Women With ER-positive/HER2-negative, Early Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Objective Reponse Rate (ORR) [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
  • Pathologic complete response (pCR) rate in breast and axilla (total pCR) [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Ki67 levels [ Time Frame: Up to Week 17 or 18 ] [ Designated as safety issue: No ]
  • Preoperative endocrine prognostic index (PEPI) scroe [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change in tumor volume [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 21-22 weeks ] [ Designated as safety issue: No ]
  • Health-related quality of life measured by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30/BR23 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: November 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Letrozole + GDC-0032
Participants will receive 2.5 milligram (mg) letrozole orally once daily (QD) along with GDC-0032 at 4 mg orally on a 5 days-on/2 days-off schedule for a total of 16 weeks.
Drug: GDC-0032
GDC-0032 will be administered orally at 4 mg daily on 5 days-on/2 days-off schedule for up to 16 weeks.
Other Name: Taselisib
Drug: Letrozole
Letrozole will be administered orally at 2.5 mg QD for 16 weeks.
Placebo Comparator: Letrozole + Placebo
Participants will receive 2.5 mg letrozole orally QD along with placebo matched to GDC-0032 on a 5-days-on/2-days-off schedule for a total of 16 weeks.
Drug: Letrozole
Letrozole will be administered orally at 2.5 mg QD for 16 weeks.
Other: Placebo
Placebo matched to GDC-0032 will be administered orally daily on 5 days-on/2 days-off schedule for up to 16 weeks.

  Eligibility

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

Inclusion Criteria:

  • Female participants
  • Postmenopausal status
  • Histologically confirmed invasive breast carcinoma, with all of the following characteristics:
  • Primary tumor greater than or equal to (>/=) 2 centimeter (cm) in largest diameter (cT1-3)
  • Stage I to operable Stage III breast cancer
  • ER-positive and HER2-negative breast cancer
  • Breast cancer eligible for primary surgery
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Fasting glucose less than or equal to (</=) 125 milligrams per deciliter (mg/dL)
  • Adequate hematological, renal, and hepatic function
  • Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Exclusion Criteria:

  • Any prior treatment for primary invasive breast cancer
  • Participants with cT4 or cN3 stage breast tumors
  • Bilateral invasive, multicentric, or metastatic breast cancer
  • Participants who have undergone excisional biopsy of primary tumor and/or axillary lymph nodes or sentinel lymph node biopsy
  • Type 1 or 2 diabetes requiring antihyperglycemic medication
  • Clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis
  • Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the participants at high risk from treatment complications
  • Significant traumatic injury within 3 weeks prior to initiation of study treatment
  • Major surgical procedure within 4 weeks prior to initiation of study treatment
  • History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02273973

Contacts
Contact: Reference Study ID Number: GO28888 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 115 Study Locations
Sponsors and Collaborators
Genentech, Inc.
SOLTI Breast Cancer Research Group
Breast International Group
Austrian Breast and Colorectal Cancer Group
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02273973     History of Changes
Other Study ID Numbers: GO28888  2013-000568-28 
Study First Received: October 22, 2014
Last Updated: September 9, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 02, 2016