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Trial Title:
Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery
NCT ID:
NCT05973864
Condition:
Triple Negative Breast Neoplasms
Conditions: Official terms:
Triple Negative Breast Neoplasms
Breast Neoplasms
Pembrolizumab
Capecitabine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pembrolizumab injection
Description:
On Day 1 of each cycle for a total of 9 cycles; intravenous (IV) infusion
Arm group label:
Arm A : Pembrolizumab and capecitabine
Arm group label:
Arm B : Pembrolizumab alone
Other name:
KEYTRUDA®
Intervention type:
Drug
Intervention name:
Capecitabine tablets
Description:
1250 mg/m² BID, on days 1-14 of each 21-day cycle; 8 cycles Dose reduction at 825 mg/m²
BID during radiotherapy if indicated
Arm group label:
Arm A : Pembrolizumab and capecitabine
Other name:
Xeloda
Intervention type:
Radiation
Intervention name:
Local radiotherapy
Description:
Local radiotherapy will be performed as per standard practice if indicated.
Arm group label:
Arm A : Pembrolizumab and capecitabine
Arm group label:
Arm B : Pembrolizumab alone
Summary:
The goal of this clinical trial is to evaluate the efficacity and safety of pembrolizumab
and capecitabine compare to pembrolizumab alone, on the invasive disease-free survival,
in participants who have triple negative breast cancer (TNBC) with residual disease after
neoadjuvant chemotherapy associated with pembrolizumab.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patient must have signed a written informed consent prior to any trial specific
procedures. When the patient is physically unable to give their written consent, a
trusted person of their choice, independent from the investigator or the sponsor,
can confirm in writing the patient's consent;
2. Subject ≥ 18 years of age on day of signing informed consent form;
3. Histologically proven TNBC defined as follows:
1. Human epidermal growth factor receptor 2 (HER2) negativity (American Society of
Clinical Oncology and the College of American Pathologists (ASCO/CAP)
criteria),
2. AND less than 10% of cells stained by immunohistochemistry for estrogen
receptor and Progesterone receptor;
4. TNBC patients previously treated by standard neoadjuvant chemotherapy with a minimum
of 6 cycles of immunochemotherapy containing pembrolizumab, per standard of care
(and pembrolizumab label) and anthracyclines and/or taxanes (with/without
carboplatin). Other drugs may be acceptable following discussion with the sponsor
(with the exclusion of capecitabine);
5. Complete resection of the breast tumor(s) (and of any invaded lymph node);
6. No complete pathological response, defined as residual cancer burden (RCB) Class I,
II, or III (per local assessment); Note: the final recruited population will contain
no more than 25% of patients with RCB I response.
7. Available representative formalin-fixed paraffin-embedded tumor block from surgery
specimen with its histological report;
8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2;
9. Adequate organ and bone marrow function. All screening lab tests should be performed
within 28 days before randomization;
10. Resolution to at least grade 1 of all acute toxicities from previous therapies
including immune related toxicity due to pembrolizumab, except alopecia,
immune-related endocrinopathies receiving hormone replacement, and ≤ grade 2 of
neuropathy toxicity which are allowed;
11. Minimal/maximal period for prior treatments (i.e. minimal delay from last dose of
prior treatment to cycle 1 dose 1 (C1D1)): breast surgery (the wound must have
healed prior to C1D1) ≥2 weeks (maximum 10 weeks); last pembrolizumab injection ≥3
weeks;
12. Women of child-bearing potential must have a negative serum pregnancy test within 7
days before C1D1;
13. Women of child-bearing potential and male patients must agree to use 1 effective
form of contraception from the time of the negative pregnancy test up to 6 months
after the last dose of study drugs;
14. Patient should be able and willing to comply with study visits and procedures as per
protocol;
15. Patients must be covered by the French medical insurance.
Exclusion Criteria:
1. Radiological or clinical evidence of metastatic disease documented by imaging or
clinical examination performed during screening period;
2. Has received capecitabine or other immune-checkpoint inhibitors (ICI) than
pembrolizumab in the neoadjuvant chemotherapy (NAC) regimen;
3. Has a known additional malignancy, excepted skin basal cell carcinoma, squamous cell
carcinoma of the skin, or in situ cervical cancer or previously treated malignancy
with no evidence of disease for ≥ 2 years;
4. Presents a contraindication to continue pembrolizumab treatment as per respective
summary of product characteristics (SmPC) including known hypersensitivity;
5. Previous immune-related adverse event of any grade due to pembrolizumab that led to
permanent discontinuation of pembrolizumab;
6. Presents a contraindication to capecitabine treatment as per SmPC;
7. Complete Dihydropyrimidine Dehydrogenase (DPD) deficiency;
8. Require the use of one of the following forbidden treatments during the study
treatment period:
- Any investigational anticancer therapy other than the protocol specified
treatment,
- Any concurrent chemotherapy, immunotherapy, biologic for cancer treatment,
other than the ones stated in the protocol;
9. Pregnant women or women who are breast-feeding;
10. Patients unwilling or unable to comply with the medical follow-up required by the
trial because of geographic, familial, social, or psychological reasons;
11. Persons deprived of their liberty or under protective custody or guardianship;
12. Participation in another therapeutic trial within the 30 days prior to
randomization.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 2024
Completion date:
January 2029
Lead sponsor:
Agency:
UNICANCER
Agency class:
Other
Source:
UNICANCER
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05973864
