Phase 2
Completed N=202
Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer
Source: ClinicalTrials.gov NCT01698918 ↗Enrolled (actual)
202
Serious AEs
31.4%
Results posted
Feb 2022
Primary outcomePrimary: First-line Treatment: Progression-free Survival (PFS) — NA Months
Summary
The purpose of this study was to assess the efficacy and safety of first-line treatment with everolimus plus letrozole in postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer.
Moreover, the study also aimed to investigate the efficacy and safety of second line treatment with everolumus plus examestane in participants whose disease progressed during everolimus plus letrozole therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY First-line Treatment: Progression-free Survival (PFS) |
NA | — |
| SECONDARY First-line Treatment: Overall Response Rate (ORR) |
45.0 | — |
| SECONDARY First-line Treatment: Clinical Benefit Rate (CBR) |
74.3 | — |
| SECONDARY Second-line Treatment: Progression-free Survival (PFS) |
3.7 | — |
| SECONDARY Second-line Treatment: Overall Response Rate (ORR) |
6.0 | — |
| SECONDARY Second-line Treatment: Clinical Benefit Rate (CBR) |
28.0 | — |
| SECONDARY Overall Survival (OS) |
NA | — |
| SECONDARY First-line Treatment: Time to First Stomatitis Episode as Assessed by the Oral Stomatitis Daily Questionnaire (OSDQ) |
1.7 | — |
| SECONDARY First-line Treatment: Duration of First Stomatitis Based on OSDQ |
12.3 | — |
| SECONDARY First-line Treatment: Number of Participants With Shift of Response in OSDQ Score on Overall Health at the End of the First Stomatitis Episode |
2; 1; 1; 1; 1; 1 | — |
| SECONDARY First-line Treatment: Number of Participants With Shift of Response in OSDQ Score on Mouth and Throat Soreness at the End of the First Stomatitis Episode |
3; 22; 12; 3; 13; 7 | — |
| SECONDARY First-line Treatment: Number of Participants With Shift of Response in OSDQ Score on Mouth and Throat Soreness Limiting Swallowing, Drinking, Eating, Talking and Sleeping at the End of the First Stomatitis Episode |
40; 3; 1; 7; 6; 3 | — |
| SECONDARY First-line Treatment: Number of Participants With Shift of Response in OSDQ Score on Mouth Pain Severity at the End of the First Stomatitis Episode |
5; 10; 6; 1; 1; 1 | — |
| SECONDARY First-line Treatment: Number of Participants With Shift of Response in OSDQ Score on Mouth Pain Severity Affecting Daily Activities at the End of the First Stomatitis Episode |
33; 1; 1; 7; 4; 2 | — |
| SECONDARY First-line Treatment (Stomatitis Sub-study): Time to First Stomatitis Episode as Assessed by the OSDQ |
1.4; 2.3 | — |
| SECONDARY First-line Treatment (Stomatitis Sub-study): Duration of First Stomatitis Based on OSDQ |
NA; 13.7 | — |
| SECONDARY First-line Treatment (Stomatitis Sub-study): Number of Participants With Shift of Response in OSDQ Score on Overall Health at the End of the First Stomatitis Episode |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY First-line Treatment (Stomatitis Sub-study): Number of Participants With Shift of Response in OSDQ Score on Mouth and Throat Soreness at the End of the First Stomatitis Episode |
1; 3; 2; 1; 3; 1 | — |
| SECONDARY First-line Treatment (Stomatitis Sub-study): Number of Participants With Shift of Response in OSDQ Score on Mouth and Throat Soreness Limiting Swallowing, Drinking, Eating, Talking and Sleeping at the End of the First Stomatitis Episode |
6; 2; 1; 1; 1; 5 | — |
| SECONDARY First-line Treatment (Stomatitis Sub-study): Number of Participants With Shift of Response in OSDQ Score on Mouth Pain Severity at the End of the First Stomatitis Episode |
1; 1; 2; 2; 1; 1 | — |
| SECONDARY First-line Treatment (Stomatitis Sub-study): Number of Participants With Shift of Response in OSDQ Score on Mouth Pain Severity Affecting Daily Activities at the End of the First Stomatitis Episode |
5; 1; 2; 1; 1; 1 | — |
| SECONDARY Number of Participants With Clinical Benfit During Extension Phase |
34; 6; 30; 5; 28; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with metastatic or locally advanced, unresectable breast cancer not amenable to curative treatment by surgery or radiotherapy
- Histological or cytological confirmation of ER+/ HER2- breast cancer
- Postmenopausal women
- No prior treatment for metastatic breast cancer
Exclusion Criteria
- Patients with only non-measurable lesions other than bone metastases (e.g., pleural effusion, ascites, etc)
- Patients who had received prior hormonal or any other systemic therapy for metastatic breast cancer. Patients might have received prior neoadjuvant or adjuvant endocrine therapy. In the case of neoadjuvant or adjuvant NSAI (letrozole/anastrozole) therapy patients must have completed therapy at least 1 year prior to study enrollment.
- Previous treatment with mTOR inhibitors.
- Known hypersensitivity to mTOR inhibitors, e.g., sirolimus (rapamycin).
Other protocol-defined inclusion/exclusion criteria might apply
Data sourced from ClinicalTrials.gov (NCT01698918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.