Clinical trial in patients with advanced breast cancer (hormone receptor-positive, HER2-negative) receiving palbociclib and standard therapy with an aromatase inhibitor or fulvestrant after prior endocrine therapy.

An open-label, multi-center, sINGlE arm clinical study to evaluate treatment efficacy and quality of life in women with hormone-receptor-positive, HER2-negative loco-regionally recurrent or metastatic breast cancer receiving palbociclib (PD 0332991) in combination with an aromatase inhibitor, or fulvestrant after prior endocrine therapy (INGE-B) - INGE-B

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001603-32-DE

Enrollment

360

Registered

2016-02-04

Start date

2016-06-14

Completion date

Unknown

Last updated

2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The study population includes postmenopausal patients with advanced (locally recurrent, inoperable and/or metastatic), HR+, HER2- breast cancer. For peri-/premenopausal patients, endocrine therapy has to be combines with a luteinizing hormone-releasinghormone (LRHR) agonist. MedDRA version: 21.1 Level: LLT Classification code 10072737 Term: Advanced breast cancer System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System

Interventions

Trade Name: Ibrance Product Name: Ibrance Product Code: PD 0332991 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Palbociclib CAS Number: 827022-32-2 Current Sponsor code: PD 0332991 Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with proven diagnosis of advanced adenocarcinoma of the breast (locally advanced, inoperable or metastatic disease). - Patients with hormone-receptor-positive (HR+) disease, defined as ER+ and/or PgR+ - Patients with human-epidermal-growth-factor-receptor-2-negative (HER2-) disease - Pre-/perimenopausal women receiving concomitant therapy with an luteinizing hormone-releasing hormone (LHRH) agonist or postmenopausal status - Patients scheduled for palliative treatment with the combination of palbociclib and letrozole for first- or later-line, anastrozole for first-line, exemestane for first-line, or fulvestrant for first-or later-line after prior endocrine failure. - Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180

Exclusion criteria

Exclusion criteria: - Patient has received prior treatment with any CDK inhibitor - Prior adjuvant therapy with the respective endocrine combination partner if last intake <12 months prior to entering the study - Prior palliative therapy with the respective endocrine combination partner - More than one palliative chemotherapy for patients in treatment group 5 (second or later line, Palbociclib and Letrozole) and group 6 (Second or leter line, Palbociclib and Fulvestrant after prior endocrine therapy) - Patient has known, not-irradiated CNS metastases

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of palbociclib in addition to an aromatase inhibitor or fulvestrant after prior endocrine therapy in pre-/perimenopausal and postmenopausal women with HR+/HER2- advanced breast cancer (locally advanced, inoperable or metastatic) as first or later-line of treatment.;Secondary Objective: -To assess safety and tolerability -To assess efficacy -To assess treatment adherence -To assess health-related quality of life (QoL), fatigue, and anxiety and depression -To compare quality of life with real-life patients receiving first-line chemotherapy in the non-interventional MaLife study -To physician’s assessment of patient’s overall health status and change in health status -To explore whether organ-specific symptoms can serve as indicators for progressive disease -To establish a decentral, virtual biobank for the future collection and central analyses of predictive biomarkers of the CDK4/6 pathway ;Primary end point(s): Primary endpoint of this study is to determine the Clinical Benefit Response (CBR) defined as proportion of patients with best overall response CBR is defined as complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 ;Timepoint(s) of evaluation of this end point: At 24 weeks after start of treatment with palbociclib and the respective combination partner.	—

Measure

Time frame

Main Objective: To evaluate the efficacy of palbociclib in addition to an aromatase inhibitor or fulvestrant after prior endocrine therapy in pre-/perimenopausal and postmenopausal women with HR+/HER2- advanced breast cancer (locally advanced, inoperable or metastatic) as first or later-line of treatment.;Secondary Objective: -To assess safety and tolerability -To assess efficacy -To assess treatment adherence -To assess health-related quality of life (QoL), fatigue, and anxiety and depression -To compare quality of life with real-life patients receiving first-line chemotherapy in the non-interventional MaLife study -To physician’s assessment of patient’s overall health status and change in health status -To explore whether organ-specific symptoms can serve as indicators for progressive disease -To establish a decentral, virtual biobank for the future collection and central analyses of predictive biomarkers of the CDK4/6 pathway ;Primary end point(s): Primary endpoint of this study is to determine the Clinical Benefit Response (CBR) defined as proportion of patients with best overall response CBR is defined as complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 ;Timepoint(s) of evaluation of this end point: At 24 weeks after start of treatment with palbociclib and the respective combination partner.

—

Secondary

Measure	Time frame
Secondary end point(s): To assess safety and tolerability - Adverse Events as characterized by type, frequency, severity (as graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v.4.03), and seriousness until PD (or start of next anti-cancer therapy, whatever comes first) - Any laboratory abnormalities - Frequency and duration of hospitalizations To assess efficacy - CBR =24 weeks - Progression free survival (PFS) - Overall survival (OS) - CBR at 48 weeks of treatment - PFS rate after 48 weeks (all patients) and after 2 years of treatment (first-line patients only) - OS rate after 48 weeks (all patients), thereafter yearly until EOS (first-line patients only)ly) To assess treatment adherence - Time on treatment - Reasons for discontinuation of treatment - Dose adjustments (frequency, reason) - Patient diary until EOT To assess Health-related quality of life (QoL), fatigue, and anxiety and depression - Health-related QoL will be assessed with the FACT-B (Functional Assessment of Cancer Therapy-Breast) questionnaire every 12 weeks until PD (or start of next anti-cancer therapy, whatever comes first) - Fatigue will be assessed with the BFI (Brief Fatigue Inventory) questionnaire every 12 weeks until PD (or start of next anti-cancer therapy, whatever comes first) - Depression and anxiety be assessed with the HADS-D (Hospital Anxiety and Depression Scale) questionnaire every 12 weeks until PD (or start of next anti-cancer therapy, whatever comes first) To assess Physician’s assessment of patient’s overall health status and change in health status compared to previous visit - Assessed with 2 item questionnaire each cycle/at scheduled patient visit until progression of disease or start of next anti-cancer therapy whatever comes first. ;Timepoint(s) of evaluation of this end point: Please see above Either at 24 weeks, at 48 weeks, after 2 years or at time point of progressive disease or start of next anti cancer therapy	—

Measure

Time frame

Secondary end point(s): To assess safety and tolerability - Adverse Events as characterized by type, frequency, severity (as graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v.4.03), and seriousness until PD (or start of next anti-cancer therapy, whatever comes first) - Any laboratory abnormalities - Frequency and duration of hospitalizations To assess efficacy - CBR =24 weeks - Progression free survival (PFS) - Overall survival (OS) - CBR at 48 weeks of treatment - PFS rate after 48 weeks (all patients) and after 2 years of treatment (first-line patients only) - OS rate after 48 weeks (all patients), thereafter yearly until EOS (first-line patients only)ly) To assess treatment adherence - Time on treatment - Reasons for discontinuation of treatment - Dose adjustments (frequency, reason) - Patient diary until EOT To assess Health-related quality of life (QoL), fatigue, and anxiety and depression - Health-related QoL will be assessed with the FACT-B (Functional Assessment of Cancer Therapy-Breast) questionnaire every 12 weeks until PD (or start of next anti-cancer therapy, whatever comes first) - Fatigue will be assessed with the BFI (Brief Fatigue Inventory) questionnaire every 12 weeks until PD (or start of next anti-cancer therapy, whatever comes first) - Depression and anxiety be assessed with the HADS-D (Hospital Anxiety and Depression Scale) questionnaire every 12 weeks until PD (or start of next anti-cancer therapy, whatever comes first) To assess Physician’s assessment of patient’s overall health status and change in health status compared to previous visit - Assessed with 2 item questionnaire each cycle/at scheduled patient visit until progression of disease or start of next anti-cancer therapy whatever comes first. ;Timepoint(s) of evaluation of this end point: Please see above Either at 24 weeks, at 48 weeks, after 2 years or at time point of progressive disease or start of next anti cancer therapy

—

Countries

Germany

Contacts

Public ContactClinical Trial Information Desk

iOMEDICO AG

info@iomedico.com+49761152420

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026