Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Hormones

Everolimus

Exemestane

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Aromatase Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Xentuzumab

Placebo

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.

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

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

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

1. studies in products where Boehringer Ingelheim is not the license holder;
2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

Progression-free survival (PFS) defined as the time from randomisation until progressive disease (PD) according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) in combination with modified MD Anderson Criteria (for bone lesion assessment), based on blinded independent assessment or death from any cause, whichever occurred earlier. As per RECIST, PD is defined as at least a 20% increase in the sum of diameters of target lesions, unequivocal progression of non-target lesions or the appearance of new lesions.

Overall survival (OS) defined as the time from randomisation until death from any cause. For patients with 'event' as an outcome for OS:

OS\[days\] = date of outcome - date of randomisation + 1.

For patients with 'censored' as an outcome for OS:

OS (censored)\[days\] = date of outcome - date of randomisation + 1.

Disease control (DC) was defined as a best overall response (BOR) of either complete response (CR), partial response (PR), stable disease (SD) or Non-CR/No-PD. SD and Non-CR/Non-PR must have been observed up until at least week 24 tumor assessment. BOR was defined according to RECIST v1.1 in combination with modified MD Anderson Criteria (for bone lesion assessment) based on all evaluable tumor assessments from randomisation until the earliest of PD, start of subsequent anti-cancer therapy, loss to follow-up, withdrawal of consent or death. To be aligned with the primary endpoint derivation, tumor assessments after two or more consecutively misses assessments were not considered. DC was assessed by independent reviewers.

Duration of disease control (DC), defined as the time from randomisation until the earliest of disease progression (according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) in combination with modified MD Anderson Criteria (for bone lesion assessment) or death from any cause, among patients with DC. Duration of DC was assessed by independent reviewers.

The duration of DC was calculated as followed:

For patients with disease progression or death:

Duration of DC \[days\] = date of outcome - date of randomisation + 1

For patients without disease progression or death:

Duration of DC (censored) \[days\] = date of outcome - date of randomisation + 1

Number of participants with objective response (OR) by independent assessment. OR is defined as a best overall response of complete response (CR) or partial response (PR). Best overall response is defined according to RECIST v1.1 in combination with modified MD Anderson Criteria (for bone lesion assessment) and will consider all tumor assessments from randomisation until the earliest of PD, start of subsequent anti-cancer therapy, loss to follow-up, withdrawal of consent or death. To be aligned with the primary endpoint derivation, tumor assessments after two or more consecutively misses assessments were not considered.

Time to pain progression or intensification of pain palliation was defined as the time from randomisation until the earliest of:

* 2 point increase from baseline in the Brief Pain Inventory - Short Form (BPI-SF), Item 3 (worst pain), without a decrease (of ≥1 point) from baseline analgesics use (via the 8-point Analgesic Quantification Algorithm \[AQA\]), or
* 2 point increase from baseline in the AQA, or Death.

Boehringer Ingelheim

\[All-cause mortality\]: Randomised Set (RS) including all randomised patients, regardless of whether they received treatment or not.

\[Serious and other adverse events\]: Treated Set (TS) including all patients who are documented to have received and taken at least one dose of any study medication.

1000 mg concentrate for solution for infusion of Xentuzumab (BI 836845) (10mg/mL supplied in 20mL vials (200mg/vial)) was administered once weekly as intravenous infusion over 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.

1000 mg Xentuzumab + 10 mg Everolimus + 25 mg Exemestane

Concentrate for solution for infusion of Placebo was administered once weekly as intravenous infusion of 1 hour on day 1, 8, 15 and 22 of 28-days cycles and on day 1, 8, 15, 22, 29, 36, 43 and 50 of 56-day cycles and tablets of 10 mg of Everolimus (Afinitor®) and tablets of 25 mg Exemestane (Aromasin®) were administered orally once per day at approximately the same time of day, after a meal.

Placebo + 10 mg Everolimus + 25 mg Exemestane

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Randomised Set (RS): The randomised set included all randomised patients, regardless of whether they received treatment or not.

Cox proportional hazards model stratified for presence of baseline bone-only metastases, prior cyclin-dependent kinase (CDK) 4/6 inhibitor treatment and menopause status.

Progression Free Survival (PFS)

Overall Survival (OS)

Number of Patients With Disease Control (DC)

Randomised Set (RS): The randomised set included all randomised patients, regardless of whether they received treatment or not. Only participants with disease control are reported.

Duration of Disease Control (DC)

Number of Participants With Objective Response (OR)

Time to Pain Progression or Intensification of Pain Palliation

Overall Study

Fulvestrant

Letrozole

Anastrozole

Antineoplastic Agents, Hormonal

Xentuzumab + Abemaciclib + Letrozole (Dose 2)

Xentuzumab + Abemaciclib + Anastrozole (Dose 3)

Xentuzumab + Abemaciclib + Fulvestrant (Dose 4)

Once weekly administrated through one hour intravenous infusion

Treatment/28-day cycle p.o. Q12H on Days 1-28 (dose determined in Cohort A) Abbreviations: PO = orally; Q12H = every 12 (± 2) hours

Abemaciclib

Once a month, with an additional dose given two weeks after the first dose. Each dose is given as two slow injections lasting one to two minutes, with one injection being given into the muscle of each buttock

Treatment/28-day cycle p.o. Q12H on Days 1-28 (dose determined in Cohort D) Abbreviations: PO = orally; Q12H = every 12 (± 2) hours

This is a study in adult patients with different types of cancer. The purpose of this study is to find a safe dose of:

* Xentuzumab in combination with abemaciclib
* Xentuzumab in combination with abemaciclib and hormonal therapies The study also tests whether these medicines make tumours shrink in participants with lung and breast cancer.

Participants can stay in the study as long as they benefit from and can tolerate treatment. All participants get xentuzumab infusions and abemaciclib tablets. Participants who have breast cancer get different types of hormonal therapies in addition to xentuzumab and abemaciclib.

For all participants, the size of the tumour is measured regularly. Doctors also regularly check the general health of the participants."

This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer.

An Open Label, Phase Ib, Dose-escalation Study Evaluating the Safety and Tolerability of Xentuzumab and Abemaciclib in Patients With Locally Advanced or Metastatic Solid Tumours and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-positive, HER2-, Breast Cancer, Followed by Expansion Cohorts.

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	NCT03659136	Breast Neoplasm...	Xentuzumab Placebo Everolimus Exemestane	18 Years -	Boehringer Ingelheim
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	NCT03659136	Breast Neoplasm...	Xentuzumab Placebo Everolimus Exemestane	18 Years -	Boehringer Ingelheim
This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer.	NCT03099174	Neoplasms Breast Neoplasm...	Xentuzumab Abemaciclib Letrozole Anastrozole Fulvestrant Abemaciclib	18 Years -	Boehringer Ingelheim

Spots Global Cancer Trial Database for xentuzumab

Every month we try and update this database with for xentuzumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for xentuzumab

Every month we try and update this database with for xentuzumab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for xentuzumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.