Breast Cancer Study of Stereotactic Body Radiation Therapy (SBRT) Combined Neoadjuvant Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-25

Study Completion Date

2028-12-31

Brief Summary

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The study is being conducted to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) combined neoadjuvant treatment for patients with triple-negative and hormone receptor-positive, HER2-negative breast cancer

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TNBC

Group Type EXPERIMENTAL

SHR-1316 at a dose 20mg/kg q3w

Intervention Type DRUG

Combination of SBRT and SHR1316, followed by SHR1316 plus nab-paclitaxel and carboplatin or cisplatin

SBRT

Intervention Type RADIATION

radiation therapy for breast cance before surgery.

HER2-/HR+BC

Group Type EXPERIMENTAL

SHR6390 at a dose of 150mg orally, daily

Intervention Type DRUG

SHR6390 plus exemestane with/without ovarian function suppression/ablation (OFS) after SBRT

SBRT

Intervention Type RADIATION

radiation therapy for breast cance before surgery.

Interventions

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SHR-1316 at a dose 20mg/kg q3w

Combination of SBRT and SHR1316, followed by SHR1316 plus nab-paclitaxel and carboplatin or cisplatin

Intervention Type DRUG

SHR6390 at a dose of 150mg orally, daily

SHR6390 plus exemestane with/without ovarian function suppression/ablation (OFS) after SBRT

Intervention Type DRUG

SBRT

radiation therapy for breast cance before surgery.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Confirmed histologic diagnosis of invasive adenocarcinoma of the breast
* ER, PR and HER2 testing, and
* TNBC patients （ HER2-neu 0-1+ by IHC or FISH-negative by ASCO CAP guidelines）
* ER-positive and HER2-negative breast cancer
* tumor measuring ≥2 cm in maximal diameter as measured by any available standard of care imaging (mammogram, breast ultrasound, breast MRI)
* Any nodal status
* ECOG Performance Status of 0 -1
* Screening laboratory values must meet the following criteria:

i. Absolute neutrophil count (ANC) ≥1.5 × 109/L ii. Platelets ≥100 × 109/L iii. Hemoglobin ≥ 10.0 g/dl for TNBC, ≥ 10.0 g/dl for HR+/HER2-BC iv. Serum creatinine ≤1.5 x upper limit of normal (ULN) v. AST ≤ 2.5 xULN vi. ALT ≤ 2.5 x ULN vii. Total bilirubin ≤ 2.5 xULN viii left ventricular ejection fraction ≥ 50%.

Exclusion Criteria

* Any kind of prior treatment for breast cancer, including chemotherapy, radiotherapy, endocrine therapy and so on
* Inflammatory breast cancer
* Pregnant and lactating women;
* distant metastasis
* patients who have participated in other clinical trials.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No