A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Metastatic Breast Cancer
- Conditions
- Breast cancerBreast carcinoma10006291
- Registration Number
- NL-OMON51870
- Lead Sponsor
- Merck Sharp & Dohme (MSD)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
The main inclusion criteria are listed here. For a complete list of inclusion
please refer to the research protocol.
1. Has locally recurrent inoperable or metastatic HR+/HER2- breast cancer,
which has not been previously treated with cytotoxic chemotherapy in the
noncurative setting.
2. Has progressed on prior endocrine therapy and is now a chemotherapy
candidate, meeting the characteristics in regard to previous treatments of one
of the 4 groups.
3. Has presented a documented radiographic disease progression
4. Is a chemotherapy candidate that meets the criteria as described in the
protocol.
5. Provides a new or the last obtained core biopsy.
6. Has centrally confirmed PD-L1 CPS >=1 and HR+ (ER and/or PgR) /HER2- breast
cancer as defined by the most recent ASCO/CAP guidelines on most recent tumor
biopsy.
7. Has an ECOG Performance Status of 0 or 1, as assessed within 7 days prior to
the first dose of study treatment.
8. Demonstrates adequate organ function, within 10 days prior to the start of
study treatment, as defined in the protocol.
9. Participants are at least 18 years of age on the day of signing informed
consent
10. Male participants are eligible to participate if they agree to the criteria
as defined in the protocol during the study intervention period and for at
least 6 months after the last dose of chemotherapy.
11. A female participant is eligible to participate if she is not pregnant or
breastfeeding, and at least 1 of the conditions defined in the protocol.
12. The participant (or legally acceptable representative if applicable)
provides documented informed consent for the study.
The main exclusion criteria are listed here. For a complete list of exclusion
please refer to the research protocol.
1. Has breast cancer amenable to treatment with curative intent.
2. Has a history or current evidence of any condition, therapy, or laboratory
abnormality as defined in the protocol.
3. Has significant cardiac disease as defined in the protocol
4. Has advanced/metastatic, symptomatic visceral spread at risk of rapidly
evolving into life-threatening complications, see more information in the study
protocol.
5. Has skin only disease. Participants who have metastatic disease fulfilling
the previous criteria in addition to skin disease can be enrolled.
6. Has a known germline BRCA mutation and has not received previous treatment
with PARP inhibition either in the adjuvant or metastatic setting. Single-agent
PARP inhibitor therapy does not count as a line of endocrine therapy.
7. Has received prior chemotherapy for locally recurrent inoperable or
metastatic breast cancer.
8. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2
agent or with an agent directed to another stimulatory or coinhibitory T-cell
receptor (eg, CTLA-4, OX-40, CD137).
9. Has received prior systemic anticancer therapy with other investigational
agents within 4 weeks prior to randomization.
10. Has received prior radiotherapy within 2 weeks of start of study
intervention or radiation-related toxicities requiring corticosteroids.
11. Has received a live or live attenuated vaccine within 30 days prior to the
first dose of study intervention.
12. Has received an investigational agent or has used an investigational device
within 4 weeks prior to study intervention administration.
13. Has a diagnosis of immunodeficiency or is receiving chronic systemic
steroid therapy or any other form of immunosuppressive therapy as defined in
the protocol.
14. Has a known additional malignancy that is progressing or has required
active treatment within the past 3 years.
15. Has known active CNS metastases as defined in the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To compare pembrolizumab plus chemotherapy to placebo plus chemotherapy with<br /><br>respect to PFS<br /><br>- To compare pembrolizumab plus chemotherapy to placebo plus chemotherapy with<br /><br>respect to OS</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To compare pembrolizumab plus chemotherapy to placebo plus chemotherapy with<br /><br>respect to ORR<br /><br>- To compare pembrolizumab plus chemotherapy to placebo plus chemotherapy with<br /><br>respect to DCR<br /><br>- To evaluate DOR<br /><br>- To evaluate the safety and tolerability of pembrolizumab plus chemotherapy.</p><br>