Phase 4
N=52
An Open Label Study of Postmenopausal Women With Oestrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Treated With Everolimus (RAD001) With Exemestane, With Exploratory Epigenetic Marker Analysis
Oestrogen Receptor Positive Advanced Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01743560 ↗Enrolled (actual)
52
Serious AEs
44.9%
Results posted
Apr 2019
Primary outcome: Primary: Best Overall Response of Everolimus and Exemestane Treatment in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer — 39; 10; 0; 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- RAD001 (Drug); Exemestane (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response of Everolimus and Exemestane Treatment in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer |
39; 10; 0; 7; 18; 15 | — |
| PRIMARY Overall Response Rate of Everolimus and Exemestane Treatment in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer |
14.3 | — |
| SECONDARY Progression-free Survival (PFS) Events as Per Investigators - FAS |
8; 25; 16 | — |
| SECONDARY Progression-free Survival (PFS) by Median Time in Weeks as Per Investigators - FAS |
23.6 | — |
| SECONDARY Progression-free Survival (PFS) - % Event-free Probability Estimate - FAS |
67.9; 49.1; 28.9; 18.4 | — |
| SECONDARY Overall Survival (OS) Events (Number of Deaths) - FAS |
8; 41 | — |
| SECONDARY Overall Survival (OS) - % Event-free Probability Estimate - FAS |
93.3; 83.9; 74.2; 74.2 | — |
| SECONDARY Change From Baseline EORTC Quality of Life Questionnaire of Cancer Patients QLQ-C30 at Each Time Point |
-9.0; -3.6; 1.9; -8.3; -5.1; -1.0 | — |
| SECONDARY Percentage of Patient Responses in EuroQoL 5-dimension Questionnaire - FAS |
38.8; 20.4; 18.4; 14.3; 16.3; 18.4 | — |
| SECONDARY Change From Baseline in EuroQoL 5-dimension Visual Analogue Scores - FAS |
-7.9; -6.1; -6.3; -11.6 | — |
Summary
Determine the overall response rate (ORR) at 48 weeks to everolimus (RAD001, 10mg daily p.o.) and exemestane (25mg daily p.o.) treatment in postmenopausal women with oestrogen receptor positive breast cancer who have previous experienced recurrence or progression on non-steroidal aromatase inhibitor (NSAI) therapy.
Eligibility Criteria
Inclusion Criteria
- Histological or cytological confirmation of oestrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.
- Availability of archival tumour tissue (the tissue block or slides will be sent to the central laboratory for analysis).
- Postmenopausal women. The investigator must confirm postmenopausal status. Postmenopausal status is defined either by:
- Age ≥ 55 years and one year or more of amenorrhea
- Age 1.5 × ULN
- Acute and chronic, active infectious disorders (except for Hep B and Hep C positive patients) and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome)
- Significant symptomatic deterioration of lung function. If clinically indicated, pulmonary function tests including measures of predicted lung volumes, DLco, O2 saturation at rest on room air should be considered to exclude restrictive pulmonary disease, pneumonitis or pulmonary infiltrates.
- Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A (rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, telithromycin) within the last 5 days prior to enrollment
- History of non-compliance to medical regimens
- Patients unwilling to or unable to comply with the protocol
- Another malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer
Data sourced from ClinicalTrials.gov (NCT01743560). 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.