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A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer. (BOLERO-6)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01783444
First received: January 11, 2013
Last updated: June 18, 2014
Last verified: June 2014

January 11, 2013
June 18, 2014
February 2013
April 2016   (final data collection date for primary outcome measure)
Progression Free Survival (PFS) [ Time Frame: 28 months after first patient randomized or once 150 PFS have occurred ] [ Designated as safety issue: No ]
Once 150 PFS events have occured (determined by local assessment). To estimate the hazard ratio of PFS for everolimus plus exemestane versus everolimus alone in postmenopausal women with ER positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole.
Same as current
Complete list of historical versions of study NCT01783444 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: Every 3 months following the end of study visit until 2015 (up to 3 years) ] [ Designated as safety issue: No ]
    To evaluate the treatment groups with respect to Overall Survival. End of study visit is defined as time when progression of disease recorded or death whichever comes first.
  • Overall response rate [ Time Frame: From the date of first dose of study medication until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately for 28 months ] [ Designated as safety issue: No ]
    Overall response rate (ORR) based on the local radiologist/investigator's tumor assessment (RECIST 1.1)
  • Clinical benefit rate (CBR) [ Time Frame: From the date of first dose of study medication until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 28 months ] [ Designated as safety issue: No ]
    Clinical Benefit Rate is defined as the proportion of patients with best overall response of complete response (CR), partial response (PR), or stable disease (SD) with duration of 24 weeks or longer.
  • Changes in ECOG (Eastern Cooperative Oncology Group) performance status [ Time Frame: Baseline, Day 1, every 6 weeks for approximately 8 months ] [ Designated as safety issue: No ]
    The ECOG performance status scale (1-5) allows patients to be classified as to their functional impairment, ECOG performance status will be compared to baseline ECOG performance classification.
  • Change in quality of life scores over time: EORTC (QLQ-C30)/EORTC module (BR23) [ Time Frame: Baseline, every 6 weeks for approximately 8 months ] [ Designated as safety issue: No ]
  • Time to quality of life (QoL)deterioration : TSQM score [ Time Frame: Baseline, week 3,6, 12 for approximately 8 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of Adverse Event(s) [ Time Frame: every study visit for approximately 8 months ] [ Designated as safety issue: Yes ]
  • Safety: Incidence of Serious Adverse Events [ Time Frame: every study visit for approximately 8 months ] [ Designated as safety issue: Yes ]
  • Safety: changes in vital signs when compared to baseline vital signs [ Time Frame: baseline, every study visit for approximately 8 months ] [ Designated as safety issue: Yes ]
  • Safety: changes in laboratory values compared to laboratory values obtained at the baseline visit [ Time Frame: baseline, every study visit for approximately 8 months ] [ Designated as safety issue: Yes ]
  • Overall Survival [ Time Frame: Every 3 months following the end of study visit until 2015 (up to 3 years) ] [ Designated as safety issue: No ]
    To evaluate the treatment groups with respect to Overall Survival. End of study visit is defined as time when progression of disease recorded or death whichever comes first.
  • Overall response rate [ Time Frame: From the date of first dose of study medication until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately for 28 months ] [ Designated as safety issue: No ]
    Overall response rate (ORR) based on the local radiologist/investigator's tumor assessment (RECIST 1.1)
  • Clinical benefit rate (CBR) [ Time Frame: From the date of first dose of study medication until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 28 months ] [ Designated as safety issue: No ]
    Clinical Benefit Rate is defined as the proportion of patients with best overall response of complete response (CR), partial response (PR), or stable disease (SD) with duration of 24 weeks or longer.
  • Changes in ECOG (Eastern Cooperative Oncology Group) performance status [ Time Frame: Baseline, Day 1, every 6 weeks for approximately 8 months ] [ Designated as safety issue: No ]
    The ECOG performance status scale (1-5) allows patients to be classified as to their functional impairment, ECOG performance status will be compared to baseline ECOG performance classification.
  • Change in quality of life scores over time: EORTC (QLQ-C30)/EORTC module (BR23) [ Time Frame: Baseline, every 6 weeks for approximately 8 months ] [ Designated as safety issue: No ]
  • Time to quality of life (QoL)deterioration : TSQM score [ Time Frame: Baseline, week 3,6, 12 and for approximately 8 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of Adverse Event(s) [ Time Frame: every study visit for approximately 8 months ] [ Designated as safety issue: Yes ]
  • Safety: Incidence of Serious Adverse Events [ Time Frame: every study visit for approximately 8 months ] [ Designated as safety issue: Yes ]
  • Safety: changes in vital signs when compared to baseline vital signs [ Time Frame: baseline, every study visit for approximately 8 months ] [ Designated as safety issue: Yes ]
  • Safety: changes in laboratory values compared to laboratory values obtained at the baseline visit [ Time Frame: baseline, every study visit for approximately 8 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.
Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in the Treatment of Postmenopausal Women With ER+Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Prior Letrozole or Anastrozole.

This study will assess the efficacy and tolerability of everolimus and capecitabine monotherapies compared to everolimus/exemestane combination in woman with ER + advanced breast cancer.

This is a three-arm, randomized, open label, multi-center phase II study investigating the combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg daily) versus capecitabine (1250mg/m2 twice daily for 14 days, 3-week cycle) in patients with estrogen-receptor positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole. The reference therapy (control arm) used in the course of this trial is the combination arm of everolimus plus exemestane. The investigational therapies in the context of this study are everolimus monotherapy and capecitabine monotherapy. All treatments will be taken orally until disease progression, intolerable toxicity or withdrawal of patient's informed consent. Patients will be randomly assigned with equal allocation to one of the treatment arms:

  1. Exemestane (25mg daily) in combination with everolimus (10mg daily)
  2. Everolimus (10mg daily)
  3. Capecitabine (1250mg/m2 twice daily) orally for two weeks, followed by a one week rest period in 3-weeks cycles.

Treatment assignment will be stratified by the presence of visceral disease (yes vs. no). Visceral refers to lung, liver, heart, ovary, spleen, kidney, adrenal gland, malignant pleural or pericardial effusion or malignant ascites.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Capecitabine
    Capecitabine, for oral use 1250 mg/m2 twice daily for 2 weeks followed by one week rest (3-week cycle). Capecitabine will be locally supplied by the Investigator.
    Other Name: Capecitabine monotherapy
  • Drug: Exemestane
    Exemestane tablets of 25 mg will be taken orally once per day. Dose modifications in the management of adverse events is allowed.
    Other Name: Control Arm
  • Drug: Everolimus
    Everolimus will be centrally dispensed via IWRS. Everolimus will be taken as oral tablets for oral use 10 mg (2 × 5 mg) daily.
    Other Name: RAD001
  • Experimental: Capecitabine Monotherapy
    100 patients will be randomized to the Capecitabine monotherapy arm (1250mg/m2 twice daily) orally for two weeks, followed by a one week rest period in 3-weeks cycles.
    Intervention: Drug: Capecitabine
  • Experimental: Everolimus Monotherapy
    100 patients will be randomized to this arm and will received Everolimus (10mg daily).
    Intervention: Drug: Everolimus
  • Active Comparator: Everolimus with Exemestane
    100 patients will be randomized to the control arm of this study, everolimus (10mg daily) with exemestane (25mg daily).
    Intervention: Drug: Exemestane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
April 2016
April 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

-Women with locally advanced, recurrent, or metastatic breast cancer along with confirmation of estrogen-receptor positive (ER+). Measurable disease defined as at least one lesion ≥ 10 mm by CT or MRI that can be accurately measured in at least one dimension (CT scan slice thickness ≤ 5 mm) OR • Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above

Exclusion Criteria:

-Patients who received more than one chemotherapy line. Patients with only non-measurable lesions other than lytic or mixed (lytic and blastic) bone metastasis.Previous treatment with exemestane, mTOR inhibitors, PI3K inhibitors or AKT inhibitors

Other protocol-defined inclusion/exclusion criteria may apply.

Female
18 Years and older
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States,   Argentina,   Australia,   Belgium,   Brazil,   Denmark,   Hungary,   India,   Ireland,   Lebanon,   Malaysia,   Peru,   Russian Federation,   Saudi Arabia,   Spain,   Sweden,   Thailand,   Turkey,   United Kingdom
 
NCT01783444
CRAD001Y2201
Yes
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP