Breast Cancer, Metastatic Breast CancerPhase 1/2NCT06890871
Radiotherapy with Immunotherapy and Anti-Angiogenic Therapy for Advanced HER2-Negative Breast Cancer: a Single-Arm Study
A Phase 1/2 study testing Intensity-modulated radiotherapy and Immunotherapy Therapy in people with Breast Cancer, Metastatic Breast Cancer, run by Zhongnan Hospital at 1 site in China.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Intensity-modulated radiotherapy and Immunotherapy Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2024to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;
- Has a history of immunodeficiency, including positive HIV test, or has other acquired or congenital immune deficiency diseases, or has a history of organ transplantation and allogeneic bone marrow transplantation, or has active hepatitis (refer to HBV DNA test value over 500 IU/ml or 2500 copies/mL); ⑨ The subject has poorly controlled clinical symptoms or diseases of the cardiovascular system, including but not limited to: (1) NYHA grade II or above heart failure; (2) unstable angina pectoris; (3) having had a myocardial infarction within 1 year; (4) having clinical significance of supraventricular or ventricular arrhythmias that have not been controlled by clinical intervention or still not controlled after clinical intervention;
- ⑩ Has had a serious infection within 4 weeks before the first administration of the study drug (CTCAE 5.0 > grade 2), such as severe pneumonia, sepsis, infection complications, etc. that require hospitalization treatment; Baseline chest imaging examination indicates active pulmonary inflammation, symptoms and signs of infection or need oral or intravenous antibiotic treatment within 2 weeks before the first administration of the study drug, except for preventive use of antibiotics;
- ⑪ Has a history of interstitial lung disease (excluding radiation pneumonitis or non-infectious pneumonia history that has not been treated with hormone therapy);
- ⑫ Has active pulmonary tuberculosis infection found through medical history or CT examination, or has a history of active pulmonary tuberculosis infection within 1 year before enrollment, or has a history of active pulmonary tuberculosis infection more than 1 year ago but has not received regular treatment; ⑬ Within the 5 years prior to the first use of the investigational drug, the subject was diagnosed with any other malignant tumor, except for those with low-risk metastasis and mortality risks (5-year survival rate > 90%), such as well-treated basal cell or squamous cell skin cancer or cervical carcinoma in situ, which are excluded;
- ⑭ Pregnant or lactating women;
- ⑮ According to the investigator's judgment, the subject has other factors that may force them to prematurely terminate the study, such as having other serious diseases (including mental disorders) that require combined treatment, severely abnormal laboratory test values, family or social factors that may affect the safety of the subject or the collection of trial data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Radiotherapy Combined with Immunotherapy and Anti-angiogenic Therapy in Patients with Advanced HER2-negative Breast Cancer：a Single-arm, Exploratory Clinical Study
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
- Being tested
- Intensity-modulated radiotherapy, Immunotherapy Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-modulated radiotherapyRadiation
Radiotherapy With Immunotherapy and Anti-Angiogenic Therapy
Immunotherapy TherapyDrug
Radiotherapy With Immunotherapy and Anti-Angiogenic Therapy
| Study group | Role | What they receive |
|---|---|---|
| advanced HER2-negative breast cancer | Experimental | Not described Receives: Radiation: Intensity-modulated radiotherapy; Drug: Immunotherapy Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
The proportion of subjects whose BOR was rated as CR or PR according to the RECIST 1.1 standard
Measured: If the therapeutic effect is CR or PR, the subjects must undergo confirmation no later than 3 weeks (21 days) after the first evaluation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start8 Aug 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer, Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Radiotherapy combined with Immunotherapy and anti-angiogenic therapy
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890871
- Sponsor's protocol ID
- 2023156
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy Combined with Immunotherapy and Anti-angiogenic Therapy in Patients with Advanced HER2-negative Breast Cancer：a Single-arm, Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT06890871
- Acronym / sponsor ID
- 2023156
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Radiotherapy combined with Immunotherapy and anti-angiogenic therapy
| Arm | Type | Receives |
|---|---|---|
| advanced HER2-negative breast cancer | Experimental | Radiation: Intensity-modulated radiotherapy, Drug: Immunotherapy Therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years old, and willing to participate in this clinical study;
- 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;
Key exclusion criteria (21 listed)
- Within 6 months prior to the first administration of the drug, there is a history of gastrointestinal perforation and/or fistula;
- ⑩ Has had a serious infection within 4 weeks before the first administration of the study drug (CTCAE 5.0 > grade 2), such as severe pneumonia, sepsis, infection complications, etc. that require hospitalization treatment; Baseline chest imaging examination indicates active pulmonary inflammation, symptoms and signs of infection or need oral or intravenous antibiotic treatment within 2 weeks before the first administration of the study drug, except for preventive use of antibiotics;
- ⑪ Has a history of interstitial lung disease (excluding radiation pneumonitis or non-infectious pneumonia history that has not been treated with hormone therapy);
- ⑫ Has active pulmonary tuberculosis infection found through medical history or CT examination, or has a history of active pulmonary tuberculosis infection within 1 year before enrollment, or has a history of active pulmonary tuberculosis infection more than 1 year ago but has not received regular treatment; ⑬ Within the 5 years prior to the first use of the investigational drug, the subject was diagnosed with any other malignant tumor, except for those with low-risk metastasis and mortality risks (5-year survival rate > 90%), such as well-treated basal cell or squamous cell skin cancer or cervical carcinoma in situ, which are excluded;
- ⑭ Pregnant or lactating women;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensity-modulated radiotherapyRadiotherapy With Immunotherapy and Anti-Angiogenic Therapy | Radiation | advanced HER2-negative breast cancer |
| Immunotherapy TherapyRadiotherapy With Immunotherapy and Anti-Angiogenic Therapy | Drug | advanced HER2-negative breast cancer |
Primary outcome
Objective response rate
Time frame: If the therapeutic effect is CR or PR, the subjects must undergo confirmation no later than 3 weeks (21 days) after the first evaluation.
The proportion of subjects whose BOR was rated as CR or PR according to the RECIST 1.1 standard
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intensity-modulated radiotherapy and Immunotherapy Therapy in people with Breast Cancer, Metastatic Breast Cancer, run by Zhongnan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: If the therapeutic effect is CR or PR, the subjects must undergo confirmation no later than 3 weeks (21 days) after the first evaluation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.