Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant
INGE-B
Open-label, Multi-center, sINGlE Arm Clinical Study to Evaluate Efficacy/QoL in Women With HR+, HER2-, Regionally Recurrent or Metastatic Breast Cancer Receiving Palbociclib With an AI or Fulvestrant After Prior Endocrine Therapy
1 other identifier
interventional
388
1 country
70
Brief Summary
The purpose of this study is to evaluate the efficacy and quality of life in women with advanced breast cancer (locally advance inoperable or metastatic adenocarcinoma of the breast), HR+ / HER2-, who are treated with an aromatase inhibitor or fulvestrant as baseline therapy in combination with palbociclib (Ibrance)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Sep 2016
Typical duration for phase_2 breast-cancer
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2016
CompletedStudy Start
First participant enrolled
September 6, 2016
CompletedFirst Posted
Study publicly available on registry
September 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2023
CompletedMarch 13, 2023
March 1, 2023
6.4 years
August 25, 2016
March 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Benefit Rate (CBR)
CBR is defined as complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.
24 weeks after first administration of Palbociclib in combination with AI / fulvestrant
Secondary Outcomes (11)
Number of participants with Adverse Events as assessed by CTCAE V4.0
From Date of Signed informed consent until PD, assessed up to 60 months.
Clinical Benefit Rate (CBR)
48 weeks after first administration of Palbociclib in combination with AI / fulvestrant
Progression-free Survival rate
At 48 weeks (all patients) and 2 years (first-line patients only) after first administration of Palbociclib in combination with AI / fulvestrant
Overall Survival rate
At 48 weeks after first administration of Palbociclib in combination with AI / fulvestrant and yearly until EOS, assessed up to 60 months.
Time on treatment
From day of first treatment until permanent discontinuation (EOT), assessed up to 60 months.
- +6 more secondary outcomes
Study Arms (1)
Palbociclib+AI or Fulvestrant
EXPERIMENTALLetrozole as first-line or later line, Anastrozole as first-line, Exemestane as first-line, Fulvestrant as first-line or later line after prior endocrine therapy.
Interventions
Capsules (commercially available, obtained from local pharmacies), 125mg daily, 21 days, 7 days off, cycles of 28 days. Dose reductions: 100mg, 75mg (no change in administration schedule) Number of cycles: until disease progression, intolerable toxicity, death or any other reasons
Letrozole will be administered as basic therapy (commercially available tablets, obtained from local pharmacies) as followed: 2.5mg/daily, oral intake
Anastrozole will be administered as basic therapy (commercially available tablets, obtained from local pharmacies) as followed: 1mg/daily, oral intake
Exemestane will be administered as basic therapy (commercially available tablets, obtained from local pharmacies) as followed: 25mg/daily, oral intake
Fulvestrant will be administered as basic therapy (commercially available injection, obtained from local pharmacies) as followed: 500mg/once monthly, intramuscular injection
Eligibility Criteria
You may qualify if:
- Personally signed written informed consent prior to beginning protocol specific procedures, including expected cooperation of the patient for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
- Women with proven diagnosis of advanced, defined as locally advanced inoperable or metastatic, adenocarcinoma of the breast
- Hormone-receptor-positive (HR+) disease, defined as estrogen-receptor-positive (ER+) and/or progesterone-receptor-positive (PgR+)
- Human epidermal growth factor receptor 2-negative (HER2-) disease (HER2 neg/+ or HER2++ with CISH/FISH neg.)
- Pre-/perimenopausal women receiving concomitant therapy with an luteinizing hormone-releasing hormone (LHRH) agonist / ovarian ablation or postmenopausal status
- Age ≥18 years
- Measurable disease as per Response Evaluation Criteria in Solid Tumors \[RECIST\] or bone-only disease
- Patients scheduled for palliative treatment with an combination partner for first- or later-line
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate organ and marrow function
- Resolution of all acute toxic effects of prior therapy, including radiotherapy Grade \<1 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures
- Fluent in spoken and written German
You may not qualify if:
- Prior treatment with any CDK4/6 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 prior palliative chemotherapy
- \. Known hypersensitivity to letrozole, anastrozole, exemestane, fulvestrant or any of their excipients
- Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4 (refer to Appendix 15.4)
- Current use of preparations containing St. John's Wort
- Participation in other studies involving investigational drug(s) (Phases I-IV) within 2 weeks before the current study treatment begins
- QTc \> 480 msec on the screening ECG (using the QTcF formula and/or the QTcB (Bazett) formula); history of QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes
- High cardiovascular risk, including, but not limited to recent myocardial infarction, severe/unstable angina and severe cardiac dysrhythmias in the past 6 months prior to enrollment
- Patients with advanced symptomatic, visceral spread, that were at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions \[pleural, pericardial, peritoneal\], pulmonary lymphangitis, and over 50% liver involvement)
- Diagnosis of any second malignancy within the last 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
- Known, not-irradiated CNS metastases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- iOMEDICO AGlead
- Pfizercollaborator
Study Sites (70)
Research Site
Aachen, Germany
Research Site
Aschaffenburg, Germany
Unknown Facility
Augsburg, Germany
Research Site
Baden-Baden, Germany
Research Site
Berlin, Germany
Unknown Facility
Bochum, Germany
Unknown Facility
Bonn, Germany
Research Site
Bottrop, Germany
Unknown Facility
Bremerhaven, Germany
Research Site
Celle, Germany
Unknown Facility
Dessau, Germany
Research Site
Donauwörth, Germany
Research Site
Dortmund, Germany
Research Site
Dresden, Germany
Research Site
Essen, Germany
Research Site
Esslingen am Neckar, Germany
Research Site
Frankfurt, Germany
Research Site
Freiburg im Breisgau, Germany
Research Site
Gerlingen, Germany
Unknown Facility
Goslar, Germany
Research Site
Göttingen, Germany
Unknown Facility
Göttingen, Germany
Unknown Facility
Greifswald, Germany
Unknown Facility
Güstrow, Germany
Research Site
Gütersloh, Germany
Research Site
Halle, Germany
Research Site
Hamburg, Germany
Unknown Facility
Homburg, Germany
Unknown Facility
Ilsede, Germany
Unknown Facility
Kaiserslautern, Germany
Research Site
Karlsruhe, Germany
Research Site
Kassel, Germany
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Krefeld, Germany
Research Site
Langen, Germany
Research Site
Leer, Germany
Unknown Facility
Loerrach, Germany
Unknown Facility
Lübeck, Germany
Unknown Facility
Lüneburg, Germany
Unknown Facility
Mannheim, Germany
Unknown Facility
Minden, Germany
Research Site
Mönchengladbach, Germany
Research Site
Mühlhausen, Germany
Unknown Facility
Mülheim, Germany
Research Site
München, Germany
Unknown Facility
München, Germany
Research Site
Münster, Germany
Unknown Facility
Neumünster, Germany
Unknown Facility
Neuruppin, Germany
Unknown Facility
Offenburg, Germany
Unknown Facility
Oldenburg, Germany
Unknown Facility
Passau, Germany
Unknown Facility
Potsdam, Germany
Research Site
Recklinghausen, Germany
Research Site
Regensburg, Germany
Unknown Facility
Rostock, Germany
Unknown Facility
Saarbrücken, Germany
Unknown Facility
Schorndorf, Germany
Research Site
Singen, Germany
Unknown Facility
Speyer, Germany
Unknown Facility
Stade, Germany
Unknown Facility
Stolberg, Germany
Unknown Facility
Stuttgart, Germany
Unknown Facility
Traunstein, Germany
Research Site
Ulm, Germany
Unknown Facility
Villingen-Schwenningen, Germany
Unknown Facility
Westerstede, Germany
Research Site
Wilhelmshaven, Germany
Unknown Facility
Witten, Germany
Unknown Facility
Würselen, Germany
Unknown Facility
Würzburg, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
iOMEDICO AG
Freiburg / Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2016
First Posted
September 9, 2016
Study Start
September 6, 2016
Primary Completion
February 15, 2023
Study Completion
February 15, 2023
Last Updated
March 13, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share