Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients

NCT03870919

Last updated date
Study Location
Institut de Cancérologie de l'Ouest-Site Paul Papin
Angers, , 49005, France
Contact
+33 (0)1 71 93 63 63
[email protected]icancer.fr

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer Stage IV, Radiotherapy, Surgery
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. Women with newly diagnosed and histologically proven de novo adenocarcinoma of the breast, Any T, any N, with at least one metastatic site measurable and/or non-measurable according to Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 and/or PET Response Criteria in Solid Tumours (PERCIST) v1.0. For patients with only bone metastases, at least one lytic and non-irradiated lesion must be present

2. Estrogen Receptor (ER)-positive and HER2-negative breast cancer. To be considered as ER-positive, the biopsy of the primary tumour must display at least 10% of cancer cells with positive ER staining. HER2-positive is defined as IHC3+ or FISH/CISH amplified according to 2018 criteria

3. Age ≥18 years

4. Eastern Cooperative Oncology Group (ECOG) ≤2

5. Indication for treatment with palbociclib and letrozole (with or without ovarian suppression)

6. Frozen primary breast tumour sample available

7. Women of childbearing potential must have a negative serum or urine pregnancy test done within 14 days before inclusion

8. Patients must agree to use adequate contraception methods for the duration of the study and for within 21 days after completing treatment

9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and any protocol-related procedures including absence of co-morbidities preventing surgery and or radiotherapy and any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Those conditions should be discussed with the patient before registration in the trial

10. Patient affiliated to a social security system

11. Written informed consent obtained prior to performing any protocol-related procedures including screening evaluations

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


1. Patients with advanced, symptomatic, visceral spread at a risk for short-term,
life-threatening complications according to investigator judgement and at risk for
visceral crisis as defined by ABC4


2. Women with previously diagnosed and treated ipsilateral adenocarcinoma of the breast


3. Women with previously treated or concomitant contralateral breast cancer except for
Ductal carcinoma in situ (DCIS) treated with curative intent


4. Patients with another concomitant cancer


5. Concurrent enrolment in another clinical trial in which investigational therapies are
administered or administration of an investigational drug within 30 days before
inclusion


6. Pregnant women or women who are breast-feeding


7. Inability or willingness to swallow oral medication


8. Known prior severe hypersensitivity to palbociclib or any component in its formulation
including known severe hypersensitivity reactions to study drug (NCI-CTCAE v5.0 Grade
≥3)


9. Patients using drugs that could have pharmacokinetics interaction with investigational
drugs


10. HIV, hepatitis (B and C)


11. Active infection


12. Prior therapy for metastatic breast cancer (systemic or local)


13. Persons deprived of their freedom or under guardianship or incapable of giving consent

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Breast Cancer Stage IV, Radiotherapy, SurgeryLocoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients
NCT03870919
  1. Angers,
  2. Beauvais,
  3. Caen,
  4. Clermont-Ferrand,
  5. Dijon,
  6. Lille,
  7. Lyon,
  8. Marseille,
  9. Marseille,
  10. Montpellier,
  11. Nancy,
  12. Nice,
  13. Paris,
  14. Paris,
  15. Paris,
  16. Paris,
  17. Pau,
  18. Reims,
  19. Saint Cloud,
  20. Strasbourg,
  21. Toulouse,
  22. Vandœuvre-lès-Nancy,
  23. Villejuif,
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients
Official Title  ICMJE PALbociclib in Advanced Breast Cancer: Therapy INtegrating locorEgional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients
Brief Summary

Approximately 3.5% to 6% of newly diagnosed breast cancer patients are stage IV metastatic. De novo metastatic breast cancer accounts for 20% to 25% of these cases. Despite a decrease in mortality in Europe and North America due to early detection and access to treatment, breast cancer remains the 2?? leading cause of cancer deaths in developed countries after lung cancer and the world's leading cause.

In the ESME French national retrospective cohort (NCT03275311), the newly diagnosed estrogen receptor (ER)-positive and HER2-negative (luminal) metastatic patients had a 59.1 months overall survival (OS) for pre-menopausal women and 44.7 months for postmenopausal women. In the same cohort, the median OS was 47.4 months for de novo metastatic patients with hormone receptor (HR)-positive / HER2-negative breast cancer.

The most important current treatment for metastatic breast cancer remains systemic therapy. Surgery and radiation are mainly used to treat symptoms. However, more than 15 retrospective studies have assessed the impact of locoregional treatment on relapse and OS. These studies suggested an improvement of the OS in patients with de novo metastatic breast cancer thanks to the addition of locoregional treatment to systemic therapy. Recent data from the ESME cohort suggest that patients with de novo luminal or HER2-positive metastatic breast cancer may benefit from local treatment of the primary tumor.

Several prospective trials have attempted to demonstrate the benefit of locoregional treatment with mixed results. This can be explained by a limited power of statistical analysis, on the recruitment of patients with breast cancer of all types, and on a limited access to effective systemic therapies in some cases and all before the area of anti CD4/6 which is the current standard treatment in patients with HR-positive / HER2-negative luminal metastatic disease.

However, guidelines indicate that a "multimodal approach, including curative locoregional treatments, should be considered". As a result, many clinicians offer locoregional treatment of the primary tumor, especially if there is a good response to the first line of systematic treatment.

Taken together, these data underscore the need for an evaluation of the value of combined therapy - endocrine therapy - CDK4/6 inhibitor and locoregional treatment - in this population of patients with newly diagnosed HR-positive / HER2-negative breast cancer.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer Stage IV
  • Radiotherapy
  • Surgery
Intervention  ICMJE
  • Drug: Palbociclib

    The included patients will first receive the following systemic treatment according standard of care:

    • Non-steroidal aromatase inhibitor (letrozole)
    • Palbociclib
    • Monthly Luteinizing hormone-releasing hormone (LHRH) analogue for non-menopausal patients only. Surgical bilateral oophorectomy is an acceptable option.
  • Other: locoregional treatment
    After 6 courses of systemic treatment initiation, the loco-regional treatment of the primary tumour will be performed: surgery (conservative or mastectomy) with or without radiotherapy, or radiotherapy
Study Arms  ICMJE Palbociclib + locoregional treatment
All patients will receive the standard of care treatment ie Palbociclib + letrozole for 24-26 weeks. After this period, patient will have the most adapted locoregional treatment ie surgery (conservative or mastectomy) with or without radiotherapy, or radiotherapy. The palbociclib will be continued until progression
Interventions:
  • Drug: Palbociclib
  • Other: locoregional treatment
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 11, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 23, 2026
Estimated Primary Completion Date October 23, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Women with newly diagnosed and histologically proven de novo adenocarcinoma of the breast, Any T, any N, with at least one metastatic site measurable and/or non-measurable according to Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 and/or PET Response Criteria in Solid Tumours (PERCIST) v1.0. For patients with only bone metastases, at least one lytic and non-irradiated lesion must be present
  2. Estrogen Receptor (ER)-positive and HER2-negative breast cancer. To be considered as ER-positive, the biopsy of the primary tumour must display at least 10% of cancer cells with positive ER staining. HER2-positive is defined as IHC3+ or FISH/CISH amplified according to 2018 criteria
  3. Age ?18 years
  4. Eastern Cooperative Oncology Group (ECOG) ?2
  5. Indication for treatment with palbociclib and letrozole (with or without ovarian suppression)
  6. Frozen primary breast tumour sample available
  7. Women of childbearing potential must have a negative serum or urine pregnancy test done within 14 days before inclusion
  8. Patients must agree to use adequate contraception methods for the duration of the study and for within 21 days after completing treatment
  9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and any protocol-related procedures including absence of co-morbidities preventing surgery and or radiotherapy and any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Those conditions should be discussed with the patient before registration in the trial
  10. Patient affiliated to a social security system
  11. Written informed consent obtained prior to performing any protocol-related procedures including screening evaluations

Exclusion Criteria:

  1. Patients with advanced, symptomatic, visceral spread at a risk for short-term, life-threatening complications according to investigator judgement and at risk for visceral crisis as defined by ABC4
  2. Women with previously diagnosed and treated ipsilateral adenocarcinoma of the breast
  3. Women with previously treated or concomitant contralateral breast cancer except for Ductal carcinoma in situ (DCIS) treated with curative intent
  4. Patients with another concomitant cancer
  5. Concurrent enrolment in another clinical trial in which investigational therapies are administered or administration of an investigational drug within 30 days before inclusion
  6. Pregnant women or women who are breast-feeding
  7. Inability or willingness to swallow oral medication
  8. Known prior severe hypersensitivity to palbociclib or any component in its formulation including known severe hypersensitivity reactions to study drug (NCI-CTCAE v5.0 Grade ?3)
  9. Patients using drugs that could have pharmacokinetics interaction with investigational drugs
  10. HIV, hepatitis (B and C)
  11. Active infection
  12. Prior therapy for metastatic breast cancer (systemic or local)
  13. Persons deprived of their freedom or under guardianship or incapable of giving consent
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: Helene MANDUZIO, PhD+33 (0)1 71 93 63 63[email protected]
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03870919
Other Study ID Numbers  ICMJE UC-0140/1814
2019-A00570-57 ( Registry Identifier: ANSM )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
Supporting Materials:Study Protocol
Supporting Materials:Statistical Analysis Plan (SAP)
Time Frame:The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.
Access Criteria:Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.
Responsible Party UNICANCER
Study Sponsor  ICMJE UNICANCER
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Delphine Hequet, MDInstitut Curie
PRS Account UNICANCER
Verification Date September 2020

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