A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)
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| ClinicalTrials.gov Identifier: NCT02273973 |
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Recruitment Status :
Completed
First Posted : October 24, 2014
Results First Posted : May 21, 2018
Last Update Posted : May 21, 2018
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Sponsor:
Genentech, Inc.
Collaborators:
SOLTI Breast Cancer Research Group
Breast International Group
Austrian Breast and Colorectal Cancer Group
Information provided by (Responsible Party):
Genentech, Inc.
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Breast Cancer |
| Interventions |
Drug: Letrozole Other: Placebo Drug: Taselisib |
| Enrollment | 334 |
Participant Flow
| Recruitment Details | The study recruited post-menopausal participants with breast cancer in 22 countries from November 2014 to March 2017. |
| Pre-assignment Details |
| Arm/Group Title | Experimental: Taselisib + Letrozole | Placebo Comparator: Placebo + Letrozole |
|---|---|---|
 Arm/Group Description |
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks. | Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks. |
| Period Title: Overall Study | ||
| Started | 166 | 168 |
| Completed | 157 | 160 |
| Not Completed | 9 | 8 |
| Reason Not Completed | ||
| Adverse Event | 4 | 0 |
| Withdrawal by Subject | 2 | 3 |
| Death | 1 | 0 |
| Non-compliance | 1 | 0 |
| Protocol Violation | 1 | 0 |
| Progression of disease | 0 | 2 |
| Lost to Follow-up | 0 | 1 |
| Physician Decision | 0 | 1 |
| Reason not specified | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Experimental: Taselisib + Letrozole | Placebo Comparator: Placebo + Letrozole | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Participants received 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks. | Participants received 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 166 | 168 | 334 | |
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Baseline Analysis Population Description |
Intention-to-Treat (ITT) population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 166 participants | 168 participants | 334 participants | |
| 64.6 (8.5) | 64.7 (8.7) | 64.6 (8.6) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 166 participants | 168 participants | 334 participants | |
| Female |
166 100.0%
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168 100.0%
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334 100.0%
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| Male |
0 0.0%
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0 0.0%
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0 0.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 166 participants | 168 participants | 334 participants |
| White |
143 86.1%
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140 83.3%
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283 84.7%
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| American Indian or Alaskan Native |
11 6.6%
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11 6.5%
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22 6.6%
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| Asian |
6 3.6%
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6 3.6%
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12 3.6%
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| Black or African American |
1 0.6%
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5 3.0%
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6 1.8%
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| Multiple |
1 0.6%
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0 0.0%
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1 0.3%
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| Other |
3 1.8%
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6 3.6%
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9 2.7%
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| Missing |
1 0.6%
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0 0.0%
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1 0.3%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 166 participants | 168 participants | 334 participants |
| Hispanic or Latino |
36 21.7%
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48 28.6%
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84 25.1%
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| Not Hispanic or Latino |
114 68.7%
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109 64.9%
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223 66.8%
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| Not Reported |
13 7.8%
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10 6.0%
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23 6.9%
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| Unknown |
3 1.8%
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1 0.6%
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4 1.2%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
| Name/Title: | Medical Communications |
| Organization: | Hoffmann-La Roche |
| Phone: | 1-800-821-8590 |
| EMail: | genentech@druginfo.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT02273973 |
| Other Study ID Numbers: |
GO28888 2013-000568-28 ( EudraCT Number ) |
| First Submitted: | October 22, 2014 |
| First Posted: | October 24, 2014 |
| Results First Submitted: | March 6, 2018 |
| Results First Posted: | May 21, 2018 |
| Last Update Posted: | May 21, 2018 |