Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant

NCT02894398

Last updated date
Study Location
Research Site
Aachen, , , Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer, Hormone Receptor Positive Tumor, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. 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

2. Women with proven diagnosis of advanced, defined as locally advanced inoperable or metastatic, adenocarcinoma of the breast

3. Hormone-receptor-positive (HR+) disease, defined as estrogen-receptor-positive (ER+) and/or progesterone-receptor-positive (PgR+)

4. Human epidermal growth factor receptor 2-negative (HER2-) disease (HER2 neg/+ or HER2++ with CISH/FISH neg.)

5. Pre-/perimenopausal women receiving concomitant therapy with an luteinizing hormone-releasing hormone (LHRH) agonist / ovarian ablation or postmenopausal status

6. Age ≥18 years

7. Measurable disease as per Response Evaluation Criteria in Solid Tumors [RECIST] or bone-only disease

8. Patients scheduled for palliative treatment with an combination partner for first- or later-line

9. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

10. Adequate organ and marrow function

11. 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

12. Fluent in spoken and written German

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Prior treatment with any CDK4/6 inhibitor


2. Prior adjuvant therapy with the respective endocrine combination partner if last
intake <12 months prior to entering the study


3. Prior palliative therapy with the respective endocrine combination partner


4. More than one prior palliative chemotherapy


5. 5. Known hypersensitivity to letrozole, anastrozole, exemestane, fulvestrant or any of
their excipients


6. Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4
(refer to Appendix 15.4)


7. Current use of preparations containing St. John's Wort


8. Participation in other studies involving investigational drug(s) (Phases I-IV) within
2 weeks before the current study treatment begins


9. 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


10. 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


11. 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)


12. 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


13. Known, not-irradiated CNS metastases

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Breast Cancer, Hormone Receptor Positive Tumor, Human Epidermal Growth Factor 2 Negative Carcinoma of BreastStudy in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant
NCT02894398
  1. Aachen,
  2. Aschaffenburg,
  3. Augsburg,
  4. Baden-Baden,
  5. Berlin,
  6. Bochum,
  7. Bonn,
  8. Bottrop,
  9. Bremerhaven,
  10. Celle,
  11. Dessau,
  12. Donauwörth,
  13. Dortmund,
  14. Dresden,
  15. Essen,
  16. Esslingen,
  17. Frankfurt,
  18. Freiburg,
  19. Gerlingen,
  20. Goslar,
  21. Greifswald,
  22. Göttingen,
  23. Göttingen,
  24. Güstrow,
  25. Gütersloh,
  26. Halle,
  27. Hamburg,
  28. Homburg,
  29. Ilsede,
  30. Kaiserslautern,
  31. Karlsruhe,
  32. Kassel,
  33. Krefeld,
  34. Langen,
  35. Leer,
  36. Luneburg,
  37. Lörrach,
  38. Lübeck,
  39. Mannheim,
  40. Minden,
  41. Mönchengladbach,
  42. Mühlhausen,
  43. Mülheim,
  44. München,
  45. München,
  46. Münster,
  47. Neumünster,
  48. Neuruppin,
  49. Offenburg,
  50. Oldenburg,
  51. Passau,
  52. Potsdam,
  53. Recklinghausen,
  54. Regensburg,
  55. Rostock,
  56. Saarbrucken,
  57. Schorndorf,
  58. Singen,
  59. Speyer,
  60. Stade,
  61. Stolberg,
  62. Stuttgart,
  63. Traunstein,
  64. Ulm,
  65. Villingen-Schwenningen,
  66. Westerstede,
  67. Wilhelmshaven,
  68. Witten,
  69. Würselen,
  70. Würzburg,
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant
Official Title  ICMJE 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
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)
Detailed Description

This is a prospective, open-label, multi-center, single arm, non-comparative phase II study in women with HR+/HER2- advanced breast cancer receiving palbociclib in addition to an aromatase inhibitor or fulvestrant. The study will take place in Germany (85 study centers).

In total, 360 patients will be enrolled in this study. 6 treatment groups are planned. The study seeks to recruit 60 (58-62) patients per recruitment group. For first-line treatment with palbociclib - and letrozole (Enrollment Group 1), anastrozole (Enrollment Group 2), exemestane (Enrollment Group 3) or fulvestrant (Enrollment Group 4) and 60 (58-62) patients for second- or later-line treatment with palbociclib -and letrozole (Enrollment Group 5) or fulvestrant (Enrollment Group 6). Recruitment will be centrally monitored to allow closure of a respective group as soon as 60 (58-62) patients have been enrolled.

Treatment will be continued until disease progression, intolerable toxicity, death or any other reason. In case a combination partner is discontinued, palbociclib has to be discontinued. In case treatment with palbociclib is stopped, combination partner can be continued according to investigator's discretion. Irrespectively of the combination partner, the discontinuation of palbociclib is defined as end of treatment (EOT) in this study. After EOT the patient enters the follow-up period.

Primary end point is clinical benefit rate 24 weeks after the first study treatment of the patient.

A study independent, decentral, "virtual" biobank will be established. All patients will be asked to give consent for their tumor samples to be used for future investigational research. Study sites will inform the local pathologists about the patient's consent and ask for the tissue sample to be reserved for future analyses. The site is requested to collect contact details of the pathologist storing the tumor sample, the sample's identification number(s), and to document these in the eCRF.

The decision to perform subsequent investigational research studies on collected samples will be based on outcome data from this study or from new scientific findings related to the drug class or disease, as well as reagent and assay availability.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Hormone Receptor Positive Tumor
  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Intervention  ICMJE
  • Drug: Palbociclib

    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

    Other Name: Ibrance
  • Drug: Letrozole
    Letrozole will be administered as basic therapy (commercially available tablets, obtained from local pharmacies) as followed: 2.5mg/daily, oral intake
    Other Name: Femara
  • Drug: Anastrozole
    Anastrozole will be administered as basic therapy (commercially available tablets, obtained from local pharmacies) as followed: 1mg/daily, oral intake
    Other Name: Arimidex
  • Drug: Exemestane
    Exemestane will be administered as basic therapy (commercially available tablets, obtained from local pharmacies) as followed: 25mg/daily, oral intake
    Other Name: Aromasin
  • Drug: Fulvestrant
    Fulvestrant will be administered as basic therapy (commercially available injection, obtained from local pharmacies) as followed: 500mg/once monthly, intramuscular injection
    Other Name: Faslodex
Study Arms  ICMJE Experimental: Palbociclib+AI or Fulvestrant
Letrozole 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:
  • Drug: Palbociclib
  • Drug: Letrozole
  • Drug: Anastrozole
  • Drug: Exemestane
  • Drug: Fulvestrant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 8, 2019)
388
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2016)
120
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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
  2. Women with proven diagnosis of advanced, defined as locally advanced inoperable or metastatic, adenocarcinoma of the breast
  3. Hormone-receptor-positive (HR+) disease, defined as estrogen-receptor-positive (ER+) and/or progesterone-receptor-positive (PgR+)
  4. Human epidermal growth factor receptor 2-negative (HER2-) disease (HER2 neg/+ or HER2++ with CISH/FISH neg.)
  5. Pre-/perimenopausal women receiving concomitant therapy with an luteinizing hormone-releasing hormone (LHRH) agonist / ovarian ablation or postmenopausal status
  6. Age ?18 years
  7. Measurable disease as per Response Evaluation Criteria in Solid Tumors [RECIST] or bone-only disease
  8. Patients scheduled for palliative treatment with an combination partner for first- or later-line
  9. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  10. Adequate organ and marrow function
  11. 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
  12. Fluent in spoken and written German

Exclusion Criteria:

  1. Prior treatment with any CDK4/6 inhibitor
  2. Prior adjuvant therapy with the respective endocrine combination partner if last intake <12 months prior to entering the study
  3. Prior palliative therapy with the respective endocrine combination partner
  4. More than one prior palliative chemotherapy
  5. 5. Known hypersensitivity to letrozole, anastrozole, exemestane, fulvestrant or any of their excipients
  6. Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4 (refer to Appendix 15.4)
  7. Current use of preparations containing St. John's Wort
  8. Participation in other studies involving investigational drug(s) (Phases I-IV) within 2 weeks before the current study treatment begins
  9. 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
  10. 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
  11. 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)
  12. 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
  13. Known, not-irradiated CNS metastases
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02894398
Other Study ID Numbers  ICMJE iOM-04318
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party iOMEDICO AG
Study Sponsor  ICMJE iOMEDICO AG
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:iOMEDICO AGFreiburg / Germany
PRS Account iOMEDICO AG
Verification Date August 2019

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