Paclitaxel Plus Pembrolizumab vs. Paclitaxel Weekly in ER+ Luminal B Metastatic Breast Cancer

Breast Cancer Clinical Trial

— PELICAN  

Official title:

A Phase II, Randomized Study of Paclitaxel Weekly Plus Pembrolizumab Versus Paclitaxel Weekly in ER-positive, Luminal B Metastatic Breast Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03841747
• Other study ID #: 012342QM
• Secondary ID: 2018-000188-10
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 2020
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PELICAN is a randomised phase II trial that aims to evaluate the efficacy and safety of paclitaxel plus pembrolizumab relative to paclitaxel alone, in patients with locally advanced or metastatic ER-positive, HER2-negative, Luminal B breast cancer who have received no prior chemotherapy for advanced or metastatic disease. Patients will be randomised (2:1) to one of the two treatment arms: - Pembrolizumab plus Paclitaxel - Paclitaxel

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2025
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Willing and able to provide written informed consent

2. Ability to comply with the protocol

3. Female = 18 years of age

4. Histologically confirmed metastatic or locally advanced breast cancer that is Luminal B, ER+ve, HER2-ve.

5. Patients must have measurable disease.

6. Representative formalin-fixed paraffin embedded breast tumour samples from the primary or recurrent cancer.

7. ECOG performance status 0-1

8. Adequate haematologic and end-organ function within 28 days prior to the first study treatment

9. Patients of childbearing potential are eligible provided they have a negative serum or urine pregnancy test on Day 1 Cycle 1 (within 72 hours) of study treatment, preferably as close to the first dose as possible.

Exclusion Criteria:

1. Luminal A breast cancer

2. Prior chemotherapy for advanced or metastatic disease

3. Prior treatment with paclitaxel in the (neo)adjuvant setting within 12 months from the end of paclitaxel treatment and randomisation into this study

4. Patients with neuropathy = Grade 2

5. Previous systemic treatment for other neoplasms within 5 years prior to randomisation.

6. Patients with prior allogeneic stem cell or solid organ transplantation.

7. Prior treatment with CD137 agonists, AKT inhibitors, anti-CTLA-4, anti-OX-40, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents.

8. Patients must not have a diagnosis of immunodeficiency or receiving chronic systemic steroid therapy.

9. Received therapeutic oral or intravenous antibiotics within 14 days prior to randomisation.

10. Administration of a live vaccine within 30 days prior to the first dose of study drug.

11. Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL] -2) within 28days or five half-lives of the drug, whichever is shorter, prior to randomisation.

12. History of autoimmune disease.

13. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia requiring steroids, or evidence of active pneumonitis on screening chest CT scan.

14. Active infection requiring systemic therapy.

15. History of HIV infection

16. Known active hepatitis infection.

17. Known history of active tuberculosis

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Pembrolizumab
200 mg Pembrolizumab IV Q3W.
• Paclitaxel
80 mg/m2 paclitaxel IV on Days 1,8, and 15 of each 28 day cycle.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Queen Mary University of London	European Institute of Oncology, Merck Sharp & Dohme LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Progression-free survival, defined as the time from the date of randomisation to the date of first documented tumour progression (using RECIST 1.1) or death from any cause, whichever occurs first.	At 12months
Primary	Overall Survival	Overall Survival is defined as the time from date of randomisation to the date of death due to any cause in all patients.	At 24 months.
Secondary	Objective Response Rates	Objective Response Rate is defined as the proportion of the patients in the analysis population who have a CR or PR (using RECIST 1.1).	Date of first documentation of CR or PR or to the date of first documented tumour progression (using RECIST 1.1) or death from any cause, whichever occurs first, assessed up to 30 months.
Secondary	Safety and tolerability of paclitaxel plus pembrolizumab versus paclitaxel through review of all AEs and SAEs assessed by CTCAE v4.03	Incidence, nature and severity of adverse events with severity determined according to CTCAE v4.03	Date of randomisation to date of all adverse event resolution following discontinuation for any reason or death, assessed up to 30 months.