Clincosm LogoSign in Get a demo

The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT03659136
Collaborator
(none)
103
Enrollment
54
Locations
2
Arms
40.9
Actual Duration (Months)
1.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of the trial is to assess the efficacy of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
103 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
XENERA™1: A Multi-centre, Double-blind, Placebo-controlled, Randomised Phase II Trial to Compare Efficacy of Xentuzumab in Combination With Everolimus and Exemestane Versus Everolimus and Exemestane in Women With HR+ / HER2- Metastatic Breast Cancer and Non-visceral Disease
Actual Study Start Date :
Nov 28, 2018
Actual Primary Completion Date :
Aug 30, 2021
Actual Study Completion Date :
Apr 26, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Xentuzumab/everolimus/exemestane

Drug: Xentuzumab
Intravenous infusion

Drug: Everolimus
Tablet

Drug: Exemestane
Tablet
Placebo Comparator: Placebo/everolimus/exemestane

Drug: Placebo
Intravenous infusion

Drug: Everolimus
Tablet

Drug: Exemestane
Tablet

Outcome Measures

Primary Outcome Measures

  1. Progression free survival (PFS) as assessed by central review [Up to 24 months]

    Defined as time from randomisation until disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) or death from any cause, whichever occurs earlier

Secondary Outcome Measures

  1. Overall survival (OS) defined as the time from randomisation until death from any cause [Up to 3 years]

    Defined as the time from randomisation until death from any cause

  2. Disease control (DC) [Up to 24 months]

    Defined as a best overall response of complete response (CR), partial response (PR), stable disease (SD) or Non-CR/Non-Progressive Disease (Non- CR/Non-PD). SD and Non-CR/Non PD must have a minimum duration of 24 weeks from randomisation. Best overall response is defined according to RECIST version 1.1 and will consider all tumour assessments from randomisation until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow-up or withdrawal of consent

  3. Duration of DC is defined as the time from randomisation until the earliest of disease progression or death, among patients with DC [Up to 24 months]

    Defined as the time from randomisation until the earliest of disease progression or death, among patients with DC

  4. Objective response (OR) Defined as a best overall response of complete response (CR) or partial response (PR) [Up to 24 months]

    Defined as a best overall response of CR or PR. Best overall response is defined according to RECIST version 1.1 and will consider all tumour assessments from randomisation until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent

  5. Time to pain progression or intensification of pain palliation [Up to 24 months]

    Defined as the time from randomisation until the earliest of a clinically significant increase in pain (≥2-point increase from baseline in the Brief Pain Inventory- Short Form [BPI-SF] Item 3) without a decrease in analgesics use, or intensification in pain palliation (≥2-point increase in the 8-point Analgesic Quantification Algorithm [AQA]), or death

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Documented histologically confirmed breast cancer with ERand/ or PgR-positive and HER2-negative status

  • Locally advanced or metastatic breast cancer not deemed amenable to curative surgery or curative radiation therapy

  • Archival tumour sample available at the time of informed consent and provided to the central laboratory around the time of randomisation. Patients must provide a formalin-fixed paraffin embedded (FFPE) tissue biopsy sample preferably taken at the time of presentation with recurrent or metastatic disease (provision of a biopsy sample taken from the bone is not acceptable).

  • Patients must satisfy the following criteria for prior therapy:

  • Disease progression during treatment or within 12 months of completion of endocrine adjuvant therapy or

  • Disease progression while on or within 1 month after the end of prior endocrine therapy for advanced/metastatic breast cancer (Note: the endocrine therapy does not have to be the treatment immediately prior to trial entry).

  • Patients must have

  • At least one measurable non-visceral lesion according to RECIST version 1.1 in either lymph nodes, soft tissue, skin and/or

  • At least one measurable non-visceral lesion according to RECIST version 1.1 as lytic or mixed (lytic + blastic) in bone and/or

  • At least one non-measurable (lytic, mixed lytic + blastic, or blastic) bone lesion according to RECIST version 1.1

  • Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.

  • Fasting glucose <8.9 mmol/L (<160 mg/dL) and HbA1c <8.0%

  • Adequate organ function

Exclusion Criteria:

  • Previous treatment with agents targeting the IGF pathway, AKT, or mTOR pathways

  • Prior treatment with exemestane (except adjuvant exemestane stopped >12 months prior to start of study treatment as long as the patient did not recur during or within 12 months after the end of adjuvant exemestane)

  • Evidence of visceral metastasis/es (i.e. liver, lung, peritoneal, pleural metastases, malignant pleural effusions, malignant peritoneal effusions) at screening. NOTE: Patients with a past history of visceral metastases are eligible if visceral metastases have completely resolved at least 3 months

  • History or evidence of metastatic disease to the brain

  • Leptomeningeal carcinomatosis

  • More than 1 prior line of chemotherapy for HR+ HER2- metastatic breast cancer

  • Radiotherapy within 4 weeks prior to the start of study treatment

  • Use of concomitant systemic sex hormone therapy

  • History or presence of cardiovascular abnormalities

  • Known pre-existing interstitial lung disease

  • Further exclusion criteria apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ironwood Cancer and Research Centers Chandler Arizona United States 85224
2 Cancer Treatment Centers of America at Western Regional Medical Center Goodyear Arizona United States 85338
3 Beverly Hills Cancer Center Beverly Hills California United States 90211
4 University of California San Francisco San Francisco California United States 94158
5 Yale Cancer Center New Haven Connecticut United States 06510
6 Florida Cancer Specialists Fort Myers Florida United States 33901
7 University Cancer and Blood Center Athens Georgia United States 30607
8 Hematology Oncology of Indiana Indianapolis Indiana United States 46260
9 University of Minnesota Minneapolis Minnesota United States 55455
10 HCA MidAmerica Division, Inc. Kansas City Missouri United States 64132
11 Hematology Oncology Associates of Rockland Nyack New York United States 10960
12 Southwestern Regional Medical Center Tulsa Oklahoma United States 74133
13 Tennessee Oncology, PLLC Nashville Tennessee United States 37203
14 The Center for Cancer and Blood Disorders Fort Worth Texas United States 76104
15 Utah Cancer Specialists Cancer Center Salt Lake City Utah United States 84106
16 Northwest Medical Specialties, PLLC Tacoma Washington United States 98405
17 The Tweed Hospital Tweed Heads New South Wales Australia 2485
18 Peninsula Haematology & Oncology Frankston Victoria Australia 3199
19 Brussels - UNIV Saint-Luc Bruxelles Belgium 1200
20 Brussels - UNIV UZ Brussel Jette Belgium 1090
21 Kortrijk - HOSP AZ Groeninge Kennedylaan Kortrijk Belgium 8500
22 UZ Leuven Leuven Belgium 3000
23 CHU de Quebec-Universite Laval Research Centre Quebec Canada G1S 4L8
24 INS Sainte Catherine Avignon France 84000
25 HOP Victor Hugo Le Mans France 72000
26 INS Paoli-Calmettes Marseille France 13009
27 INS Curie Paris France 75248
28 HOP Européen G. Pompidou Paris France 75908
29 HOP Lyon Sud Pierre Benite France 69495
30 INS Universitaire du Cancer Toulouse France 31059
31 Universitätsklinikum Erlangen Erlangen Germany 91054
32 Vincentius-Diakonissen-Kliniken gAG Karlsruhe Germany 76135
33 General Hospital of Athens "Alexandra" Athens Greece 11528
34 University General Hospital of Heraklion Heraklion Greece 71110
35 University Hospital of Larisa, Oncology Clinic Larisa Greece 41334
36 Metropolitan Hospital, Oncology Clinic Neo Faliro, Athens Greece 18547
37 Euromedica Kyanous Stavros General Hospital Thessaloniki Greece 54645
38 Istituto Nazionale IRCCS Tumori Fondazione Pascale Napoli Italy 80131
39 Iov, Irccs Padova Italy 35128
40 Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza Roma Italy 00189
41 Fundação Champalimaud, Lisboa Portugal 1400-038
42 Hospital Beatriz Ângelo Loures Portugal 2674-514
43 Centro Hospitalar de Vila Nova de Gaia Vila Nova de Gaia Portugal 4434-502
44 Hospital Teresa Herrera A Coruña Spain 15006
45 Hospital Clínic de Barcelona Barcelona Spain 08036
46 Hospital Arnau de Vilanova Lleida Spain 25198
47 Hospital General Universitario Gregorio Marañón Madrid Spain 28007
48 Hospital Ramón y Cajal Madrid Spain 28034
49 Hospital Clínico San Carlos Madrid Spain 28040
50 Hospital Regional Universitario de Málaga Málaga Spain 29010
51 Instituto Valenciano de Oncología Valencia Spain 46009
52 Clínica Quirón de Valencia Valencia Spain 46010
53 Hospital Clínico de Valencia Valencia Spain 46010
54 St Bartholomew's Hospital London United Kingdom EC1A 7BE

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT03659136
Other Study ID Numbers:
  • 1280-0022
  • 2017-003131-11
First Posted:
Sep 6, 2018
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms
Everolimus
Exemestane

Study Results

No Results Posted as of May 17, 2022