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Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorXijing Hospital

About this trial

The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant radiotherapy followed by chemotherapy combined with immunotherapy in patients with previously untreated stage IIB-IIIC (cT3N0 or cT2-4N1-3) HR-positive and HER2-negative breast cancer. 27 enrolled patients will be assigned to receive stereotactic body radiotherapy followed by Nab-Paclitaxel combined with Toripalimab. The main question it aims th answer is that whether the combination therapy of radiotherapy, de-escalated chemotherapy, and immunotherapy could improve the pCR rate of HR-positive and HER2-negative breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged ≥18 and ≤75 years at the time of signing informed consent.

ECOG PS status of 0-1.

Clinical stage: Stage IIB, IIIA, IIIB, or IIIC

Required imaging assessments (within 28 days): Abdominal CT, ECT Bone scan, Chest CT and Brain MRI

Disqualifiers

Inflammatory Breast Cancer.

Autoimmune disease: patients with any known or suspected autoimmune disease, except: hypothyroidism due to autoimmune thyroiditis managed with hormone replacement therapy only, stable type-1 diabetes with well-controlled blood glucose.

Cardiovascular Diseases: poorly controlled hypertension despite medication (SBP >140 mmHg or DBP>90 mmHg). And with the history (within 6 months prior to enrollment) of myocardial infarction, severe/unstable angina, NYHA Class ≥2 heart failure, clinically significant arrhythmias as well as symptomatic congestive heart failure.

Interstitial lung disease, non-infectious pneumonitis, or other uncontrolled systemic diseases (e.g., diabetes, pulmonary fibrosis, acute pneumonia);

Trial design

Design model

Single group

Treatments tested in this trial

  • Stereotactic Body Radiation Therapy (SBRT)

    Radiation

    The prescribed dose of radiation is 24 Gy delivered in 3 fractions (8 Gy/fraction) using SBRT technique. Subjects received SBRT for the primary breast cancer lesion at 8Gy/Fraction each time for 3 consecutive days, 1 week before the start of systemic therapy. The first day of radiation is C1D1.

  • Toripalimab

    Drug

    Toripalimab will be administered at a fixed dose of 240 mg via intravenous infusion every 3 weeks (q3w). The first dose is given on Cycle 2 Day 1 (C2D1), followed by dosing on the first day of each subsequent cycle for a total of 4 cycles. (Toripalimab×4 240mg D1 q3w)

  • Neoadjuvant Chemotherapy

    Drug

    Combined with Toripalimab, Nab-paclitaxel will be dosed at 125 mg/m² based on body surface area, administered by intravenous infusion weekly (Days 1, 8, 15 of each 21-day cycle) for 4 cycles.(T×4, Nab-Paclitaxel 125mg/m2，D1、D8、D15 q3w).

  • Surgery

    Procedure/Surgery

    Surgery will be performed 2-6 weeks after completion of neoadjuvant therapy. The surgical approach will be determined by the investigator based on disease status and patient preference.

  • Adjuvant Chemotherapy

    Drug

    The anthracycline may be either Epirubicin (body surface area-adjusted 50 mg/m²) or Liposomal Doxorubicin (body surface area-adjusted 30 mg/m²) combined with Cyclophosphamide (body surface area-adjusted 600 mg/m²). Both drugs were administered intravenously every 3 weeks, and then the first day of each course was administered for 4 cycles. (EC×4, Epirubicin 50 mg/m² or Liposomal Doxorubicin 30 mg/m², comined with Cyclophosphamide 600 mg/m², D1, q3w)

  • Adjuvant Radiotherapy

    Radiation

    Conventional radiotherapy will be delivered to the breast/chest wall and regional lymph nodes (investigator-selected technique), with explicit prohibition of tumor bed boost irradiation.

  • Endocrine therapy

    Drug

    Investigator-selected adjuvant endocrine therapy will be deterimend according to applicable guidelines, considering menopausal status, recurrence risk, treatment history, comorbidities as well as patient preference.

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Pathologic complete response (pCR) rate according to RCB system

pCR is defined as the absence of invasive cancer in the breast primary lesion and negative regional lymph nodes (ypT0/Tis ypN0) by hematoxylin-eosin staining after completion of the neoadjuvant treatment. RCB system will be used for the pathological evaluation after neoadjuvant therapy

Time frame
Up to 12 months

Secondary outcomes

1

RCB 0/I rate

The RCB 0/I rate is defined as the percentage of patients achieving either pathological complete response (RCB-0) or minimal residual disease (RCB-I), corresponding to near-pCR status

Time frame
Up to 12 months
2

DFS and iDFS

Disease-free survival (DFS) is defined as the time from initiation of neoadjuvant therapy to the earliest occurrence of any of the following events: ipsilateral or contralateral invasive breast cancer recurrence, locoregional recurrence, distant recurrence, death from any cause, second primary non-breast malignancy, or ipsilateral/contralateral ductal carcinoma in situ (DCIS). Invasive disease-free survival (iDFS) is measured from the start of neoadjuvant therapy until invasive disease recurrence (including locoregional recurrence, ipsilateral/contralateral invasive breast cancer, distant metastasis), new primary tumors, or death from any cause.

Time frame
1 year, 2 year, 3 year and 5 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xijing Hospital

Lead sponsor

Source ClinicalTrials.gov
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