Radiotherapy with Immunotherapy and Anti-Angiogenic Therapy for Advanced HER2-Negative Breast Cancer: a Single-Arm Study

NCT06890871 | Enrolling By Invitation Phase 1

• 1 other identifier: 2023156
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment options for advanced HER2-negative breast cancer are limited. The single or combined drug therapy has a short remission time. Moreover, after multiple lines of treatment, patients are often in an awkward situation of "no more drugs available". And through literature research, it has been found that there is a synergistic effect between immunotherapy and anti-angiogenic therapy, as well as between radiotherapy and immunotherapy. This study will provide new approaches for the treatment of advanced HER2-negative breast cancer in the second-line setting, and offer new evidence-based medical evidence for patients with advanced HER2-negative breast cancer in the era of immunotherapy.

Conditions

Breast Cancer, Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  The proportion of subjects whose BOR was rated as CR or PR according to the RECIST 1.1 standard

  If the therapeutic effect is CR or PR, the subjects must undergo confirmation no later than 3 weeks (21 days) after the first evaluation.

Study Arms (1)

advanced HER2-negative breast cancer

EXPERIMENTAL

Radiation: Intensity-modulated radiotherapy; Drug: Immunotherapy Therapy

Interventions

Intensity-modulated radiotherapy RADIATION

Radiotherapy With Immunotherapy and Anti-Angiogenic Therapy

advanced HER2-negative breast cancer

Immunotherapy Therapy DRUG

Radiotherapy With Immunotherapy and Anti-Angiogenic Therapy

advanced HER2-negative breast cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, and willing to participate in this clinical study;
• Pathologically diagnosed as invasive breast cancer; patients with breast cancer confirmed by imaging to have distant metastasis;
• HER-2 negative (0/1+/2+ and FISH negative), and the pathological status of ER, PR and PD-L1 has been detected;
• ECOG score 0-2; ⑤ ≥ 2 measurable lesions (according to RECIST 1.1.);
• At least one metastatic lesion that can receive safe radiotherapy (excluding bone metastasis lesions);
• ⑦ Expected survival time \> 3 months;
• ⑧ HER2-negative breast cancer that has relapsed or metastasized after receiving ≥ 2 lines of systemic treatment;
• ⑨ Good function of major organs, and laboratory test data meet the following standards: (1) Blood routine: Absolute neutrophil count ≥ 1.5 × 109/L (or greater than the lower limit of normal value in the laboratory of the research center), platelet count ≥ 100 × 109/L, hemoglobin ≥ 90 g/L; (2) Liver function: Serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN), AST and ALT ≤ 2.5 times ULN, if the patient has liver metastasis, this standard is ≤ 5 times ULN; (3) Renal function: CrCl ≥ 60 ml/min / 1.73 m2 (calculated according to the Cockcroft-Gault formula);
• ⑩ Female subjects with reproductive capacity, and male subjects whose partner has reproductive capacity, need to adopt one medically approved contraceptive measure (such as intrauterine device, contraceptive pills or condoms) during the study treatment period, and at least 6 months after the last treatment;
• ⑪ Voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.

You may not qualify if:

• Within 6 months prior to the first administration of the drug, there is a history of gastrointestinal perforation and/or fistula;
• There is a history of uncontrollable pleural effusion, pericardial effusion or peritoneal effusion that requires repeated drainage;
• There is a history of any allergy to any component of adalimumab;
• Has received any of the following treatments:
• Within 4 weeks before the first administration of the study drug, has received any other investigational drug or the time from the last investigational drug administration is no more than 5 half-lives;
• Has been enrolled in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or a follow-up of an interventional clinical study;
• Has received anti-tumor treatment (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy or tumor embolization) within 2 weeks before the first administration of the study drug;
• Has received corticosteroids (more than 10mg of prednisone equivalent daily dose) within 2 weeks before the first administration of the study drug. Routine chemotherapy pre-treatment with hormones is allowed without dose adjustment. Other special circumstances need to be communicated with the investigator. In the absence of active autoimmune diseases, inhalation or local use of corticosteroids and doses \>10mg/day of prednisone efficacy dose are allowed as an alternative for adrenal cortical hormones;
• Has received an anti-tumor vaccine or has received live vaccines within 4 weeks before the first administration of the study drug;
• Has undergone major surgery within 6 months or has had severe trauma;
• The lesion area has received high-dose radiation therapy;
• Has received PD1/PD-L1 treatment within 6 months;
• The toxicity of previous anti-tumor treatment has not recovered to ≤CTCAE 5.0 grade 1 (except for alopecia);
• Has contraindications to radiotherapy;
• Has active autoimmune diseases, autoimmune disease history (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to some diseases or syndromes); Excluding vitiligo or cured childhood asthma/allergy, adult patients without any intervention after adulthood; Using stable doses of thyroid replacement hormones for autoimmune-mediated hypothyroidism; Using stable doses of insulin for type I diabetes;

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

#169, Donghu Road, Wuchang District, Wuhan

Wuhan, Hubei, 430071, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Radiotherapy combined with Immunotherapy and anti-angiogenic therapy

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 24, 2025
• Study Start: August 8, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)