Trial Title:
Neoadjuvant Chemotherapy + PD-1 Inhibitor+Different Radiotherapy Fractionations for HR+/HER2- Breast Cancer
NCT ID:
NCT06639672
Condition:
HR+HER2- Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Immune Checkpoint Inhibitors
Conditions: Keywords:
HR+/HER2- breast cancer
Neoadjuvant chemotherapy
Immunotherapy
Radiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chemotherapy+PD-1 inhibitor+8Gy x 3f
Description:
Radiotherapy: 8Gy x 3f, once every other day; Chemotherapy: Cycles 1-4: Albumin-bound
paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin:
90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV,
administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three
weeks
Arm group label:
Arm 1
Intervention type:
Drug
Intervention name:
Chemotherapy+PD-1 inhibitor+16Gy x 1f
Description:
Radiotherapy: 16Gy x 1f; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m²,
IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV,
administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day
1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks
Arm group label:
Arm 2
Intervention type:
Drug
Intervention name:
Chemotherapy+PD-1 inhibitor+2.67Gy x 15f
Description:
Radiotherapy: 2.67Gy x 15f; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260
mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV,
administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day
1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks
Arm group label:
Arm 3
Intervention type:
Drug
Intervention name:
Chemotherapy+PD-1 inhibitor+0.5Gy x 12-18f
Description:
Radiotherapy: 0.5Gy x 12-18f; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260
mg/m², IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV,
administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day
1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks
Arm group label:
Arm 4
Summary:
For the hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative
(HER2-) subtype of breast cancer, although surgical, radiotherapy, and endocrine
treatments have shown better survival, this subtype has a relatively poor response to
neoadjuvant chemotherapy and immunotherapy, with an approximately pCR of 20%. The low
immunogenicity result in suboptimal pCR and objective response rates for this group.
Therefore, there is an urgent need to explore new, highly effective, and low-toxicity
treatment strategies to further improve the efficacy of HR+/HER2- breast cancer.
Radiotherapy has systemic immune regulatory effects by promoting the release of antigens
from tumor cells, enhancing T-cell infiltration, and directly killing tumor cells.
Therefore, this study aims to investigate the efficacy and safety of chemotherapy
combined with PD-1 inhibitor and different radiotherapy fractionations in the neoadjuvant
treatment of HR+/HER2- breast cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Histologically or cytologically confirmed HR+/HER2- breast cancer
-
2. cT1c-2N1-2M0 or cT3N0-2M0（AJCC 7th）
-
3. ECOG performance status of 0-1;
-
4. Adequate bone marrow function, defined as: Hb ≥ 9.0 g/dL (90 g/L); ANC ≥
1,500/mcL (1.5 × 10^9/L); PLT ≥ 100,000/mcL (100 × 10^9/L) and no blood
transfusion within 3 weeks or growth factor (G-CSF, EPO) therapy within 2 weeks
prior to dosing;
-
5. Adequate liver function, defined as: TBIL ≤ 1.5× upper limit of normal (ULN);
If no liver metastases, AST and ALT ≤ 2.5× ULN; if liver metastases are
present, AST or ALT ≤ 3.0× ULN; ALP ≤ 1.5× ULN; if liver metastases ≤ 2× ULN;
Serum albumin ≥ 30g/L;
-
6. Adequate coagulation function: INR or PT, APTT ≤ 1.5× ULN. Participants on
anticoagulant therapy should have these laboratory indices closely monitored;
-
7. Adequate renal function, defined as creatinine ≤ 1.5× ULN or Ccr ≥ 50 mL/min
calculated using the Cockcroft-Gault formula corrected for body surface area;
-
8. Baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by
multiple-gated acquisition (MUGA) or echocardiogram (ECHO);
-
9. No severe organic heart disease or arrhythmias;
-
10. Women of childbearing potential (aged 15-49 years) must have a negative
pregnancy test within 7 days before starting treatment. Both male and female
participants of reproductive potential must agree to use effective
contraceptive measures during the study period and for 3 months after
discontinuation of treatment;
-
11. Voluntary signed informed consent by the study participant.
Exclusion Criteria:
-
1. Patients with a history of mental illness or those diagnosed with mental
disorders at the time of enrollment in the clinical trial.
-
2. Patients with communication barriers due to confusion, aphasia, intellectual
disability, or other reasons that prevent them from responding normally.
-
3. Poorly controlled tumor-related pain.
-
4. Patients participating in other clinical studies simultaneously.
-
5. Patients with active or past autoimmune diseases or immunodeficiencies,
including but not limited to myasthenia gravis, myositis, autoimmune hepatitis,
systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease,
antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome,
Guillain-Barré syndrome, or multiple sclerosis.
-
6. A history of idiopathic pulmonary fibrosis, organizing pneumonia (such as
obliterative bronchiolitis), drug-induced pneumonia, or idiopathic pneumonia,
or evidence of active pneumonia on chest CT scans at screening.
-
7. Active pulmonary tuberculosis.
-
8. Severe cardiovascular diseases occurring within 3 months prior to the start of
study treatment (e.g., NYHA class II or higher heart disease, myocardial
infarction, or cerebrovascular accident), unstable arrhythmias, or unstable
angina.
-
9. Patients who underwent significant surgical procedures, other than diagnostic
surgeries, within 4 weeks prior to the start of the study treatment, or are
expected to require significant surgical procedures during the study period.
-
10. Patients who had malignant tumors other than breast cancer within the last 5
years, except for malignancies in the study that have negligible risks of
metastasis or death , such as adequately treated cervical carcinoma in situ,
non-melanoma skin cancer, ductal carcinoma in situ, or stage I uterine cancer.
-
11. Patients who experienced severe infections within 4 weeks prior to the start of
the study treatment, including but not limited to those requiring
hospitalization due to infections, bacteremia, severe pneumonia, or any active
infection that may impact patient safety.
-
12. Patients who have previously received allogeneic stem cell or solid organ
transplants.
-
13. Any other diseases, metabolic dysfunctions, physical examination abnormalities,
or clinical laboratory abnormalities that contraindicate the use of the study
drug, may affect the interpretation of results, or pose a high risk of
treatment complications for the patient.
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
November 1, 2024
Completion date:
May 1, 2031
Lead sponsor:
Agency:
Lei Liu
Agency class:
Other
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06639672
