Breast CancerPhase 2NCT07647016
Trastuzumab Deruxtecan Plus ivonescImab for Hormone Receptor-positive HER2 Negative Advanced Breast Cancer Study
A Phase 2 study testing Trastuzumab Deruxtecan and ivonescimab in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
The UNITY study is a prospective, single-arm, single-center, Phase II clinical trial conducted by Fudan University Shanghai Cancer Center. It aims to evaluate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) combined with ivonescimab in patients with hormone receptor-positive (HR+), HER2-negative recurrent or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Trastuzumab Deruxtecan and ivonescimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 1 Feb 2028
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, any gender.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Histologically or cytologically confirmed Hormone Receptor-positive (HR+) and Human Epidermal Growth Factor Receptor 2 (HER2)-low or HER2-ultralow breast cancer, with evidence of locally recurrent or metastatic disease that is not amenable to curative-intent surgery or radiation therapy.
- HR positivity is defined as Estrogen Receptor (ER) positive (≥1% positive cells) and/or Progesterone Receptor (PR) positive (≥1% positive cells).
- HER2-low or HER2-ultralow expression is defined as HER2 (0 with staining), HER2 (1+), or HER2 (2+) by immunohistochemistry (IHC) with a negative in-situ hybridization (ISH) result.
- Fulfillment of these criteria from any single pathological assessment is sufficient for eligibility.
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- Life expectancy of ≥ 3 months.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
- History of recurrence or disease progression after prior treatment with a CDK4/6 inhibitor (including in the adjuvant setting). Patients have received a maximum of one line of chemotherapy for recurrent or metastatic disease. Recurrence or disease progression during or within 6 months after completion of neoadjuvant/adjuvant intravenous chemotherapy is counted as one line of therapy.
- Patients with Central Nervous System (CNS) metastases are eligible. Ventriculoperitoneal shunt to relieve intracranial pressure or use of mannitol, corticosteroids, or anticonvulsants is permitted prior to the first dose. However, the dose of such medications must be stable for at least 1 week without an increase, and neurological symptoms must be stable without worsening for at least 1 week. (Priority will be given to the enrollment of patients with CNS metastases.)
- Availability of an adequate tumor tissue sample for retrospective analysis of PD-L1 status.
- Adequate organ function, defined as follows:
- Hematology: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L; Platelets (PLT) ≥ 75 × 10⁹/L; Hemoglobin (Hb) ≥ 90 g/L (transfusion or medical support to meet this level is permitted).
- Hepatic and Renal Function: Total Bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × ULN (≤ 5.0 × ULN in the presence of liver metastases); Blood Urea Nitrogen (BUN) or Serum Creatinine (Cr) ≤ 1.5 × ULN, or Creatinine Clearance ≥ 50 mL/min (calculated by Cockcroft-Gault formula).
- Coagulation: Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN; Prothrombin Time (PT) ≤ 1.5 × ULN.
- Cardiac: QT interval corrected by Fridericia's formula (QTcF) < 470 ms for females and < 450 ms for males on a 12-lead electrocardiogram (ECG); Left Ventricular Ejection Fraction (LVEF) ≥ 50% by echocardiogram.
- Voluntary participation in the study with signed informed consent, and willingness to comply with study procedures and follow-up.
Who cannot join
- Confirmed leptomeningeal metastases by Magnetic Resonance Imaging (MRI) or lumbar puncture.
- Prior treatment with anti-PD-1/PD-L1 or anti-VEGF agents, unless both of the following conditions are met: (1) The patient did not experience disease progression during treatment with the anti-PD-1/PD-L1 or anti-VEGF agent; and (2) The time from the last dose of the anti-PD-1/PD-L1 or anti-VEGF agent to the time of recurrence or disease progression is ≥ 3 months.
- Presence of third-space fluid accumulation (e.g., massive pleural or peritoneal effusion) that cannot be controlled by drainage or other methods.
- Receipt of whole-brain radiotherapy, chemotherapy, targeted biologic therapy, immunotherapy, surgery, or endocrine therapy within 2 weeks prior to the first dose of study drug. Bone-modifying agents for the treatment of bone metastases or prevention of osteoporosis are permitted.
- Prior treatment with trastuzumab deruxtecan or any antibody-drug conjugate (ADC) containing a topoisomerase inhibitor.
- Participation in another interventional drug clinical trial within 2 weeks prior to enrollment. Participation in non-interventional studies is allowed.
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- Major surgery or significant trauma within 4 weeks prior to randomization, or anticipation of the need for major surgery during the study.
- Concurrent receipt of any other anti-cancer therapy.
- History of other malignancies within the past 5 years, except for curatively treated cervical carcinoma in situ, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and papillary thyroid carcinoma.
- History of any of the following cardiac conditions: (1) Myocardial infarction; (2) Congestive heart failure; (3) Any other cardiac condition judged by the investigator to be unsuitable for study participation.
- Known history of hypersensitivity to any component of the study drugs.
- History of immunodeficiency, including positive test for Human Immunodeficiency Virus (HIV), other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- Active hepatitis (Hepatitis B defined as HBsAg positive and HBV DNA ≥ 1000 IU/mL; Hepatitis C defined as HCV antibody positive and HCV RNA > upper limit of normal).
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Clinically significant pulmonary-specific comorbidities, including but not limited to any underlying pulmonary disease (e.g., pulmonary embolism within 3 months prior to the study, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.).
- Uncontrolled infection requiring systemic antibiotic, antiviral, or antifungal therapy.
- Clear history of neurological or psychiatric disorders, including epilepsy or dementia.
- Pregnant or breastfeeding women; women of childbearing potential with a positive pregnancy test at baseline or who are unwilling to use effective contraceptive measures throughout the study period.
- Presence of any concomitant disease that, in the investigator's judgment, could seriously compromise patient safety or interfere with completion of the study (including, but not limited to, uncontrolled severe hypertension, uncontrolled severe diabetes, active infection, etc.).
- Any other condition for which the investigator considers the patient unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ting Li contact
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Hongxia Wang, PHD, 13524491606, whx365@126.com
About this study
Official title: A Prospective, Single-arm, Single-center Phase II Clinical Study of Deruxtecan in Combination With ivonescImab in Hormone Receptor-positive HER2 Negative Advanced Breast Cancer
The UNITY study is a prospective, single-arm, single-center, Phase II clinical trial conducted by Fudan University Shanghai Cancer Center. It aims to evaluate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) combined with ivonescimab in patients with hormone receptor-positive (HR+), HER2-negative recurrent or metastatic breast cancer.
Approximately 53 patients will be enrolled. Eligible participants must have histologically confirmed advanced HR-positive breast cancer with HER2-low or HER2-ultralow expression. They must have experienced recurrence, metastasis, or disease progression after prior treatment with a CDK4/6 inhibitor (including in the adjuvant setting) and have received at most one line of systemic chemotherapy for advanced disease. The study permits the enrollment of patients with central nervous system (CNS) metastases.
Read more
The primary endpoint is the Overall Response Rate (ORR). Key secondary endpoints include Clinical Benefit Rate (CBR), Overall Survival (OS), Progression-Free Survival (PFS), safety, and patient-reported quality of life (assessed using EORTC QLQ-C30 and QLQ-BR23). Exploratory endpoints will involve the analysis of biomarkers from tumor and blood samples, as well as PAM50 molecular subtyping and its correlation with survival outcomes.
This study seeks to explore the efficacy and safety of Trastuzumab Deruxtecan in combination with ivonescimab for patients with HR-positive, HER2-negative recurrent or metastatic breast cancer, with a particular focus on the subpopulation with CNS metastases.
- Conditions
- Breast Cancer
- Being tested
- Trastuzumab Deruxtecan and ivonescimab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab Deruxtecan and ivonescimabDrug
- Trastuzumab Deruxtecan (T-DXd): Administered at a dose of 5.4 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle.
- Ivonescimab: Administered at a dose of 20 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle.
Treatment for both agents will continue until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Arm1 | Experimental | Not described Receives: Drug: Trastuzumab Deruxtecan and ivonescimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
ORR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1 .Time from randomization to disease progression or death, assessed by RECIST v1.1.
Measured: From treatment initiation until disease progression or death, assessed by RECIST v1.1., assessed up to 24 months
Secondary outcomes (6)
PFS
PFS is the time from the date of first dose until the date of objective radiographic disease progression or death (by any cause in the absence of progression).
Measured: From treatment initiation until disease progression or death, assessed by RECIST v1.1., whichever occurs first, assessed up to 24 months.
OS
OS is the time from the date of frst dose until the date of death by any cause.
Measured: From treatment initiation until death from any cause, assessed up to 36 months.
Clinical Benefit Rate
CBR is defined as the percentage of patients who achieve a Complete Response (CR), a Partial Response (PR), or have Stable Disease (SD) lasting for at least 24 weeks.
Measured: From treatment initiation until disease progression or death, assessed by RECIST v1.1., whichever occurs first, assessed up to 24 months.
Safety assessed by NCI-CTCAE v5.0
Safety and tolerability will be evaluated by monitoring and recording all adverse events (AEs). The severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0. AEs are defined as any adverse event that starts or worsens in severity on or after the first dose of study treatment.
Measured: From the first dose of study treatment until 30 days after the last dose of study treatment, assessed up to approximately 2 years.
Quality of Life Assessed by EORTC QLQ-C30
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is a validated cancer-specific quality-of-life instrument. Scores are transformed to a 0-100 scale according to the EORTC scoring manual. Higher functional scores indicate better functioning, whereas higher symptom scores indicate greater symptom burden. Change from baseline will be evaluated.
Measured: Screening, within 3 days before each treatment administration, at the end of treatment, and during safety follow-up, assessed up to 24 months.
Breast cancer-specific quality of life assessed by EORTC QLQ-BR45
The EORTC QLQ-BR45 is a validated breast cancer-specific quality-of-life questionnaire consisting of functional and symptom scales. Scores are transformed to a 0-100 scale according to the EORTC scoring manual. Higher functional scores indicate better functioning, whereas higher symptom scores indicate greater symptom burden.
Measured: Screening, within 3 days before each treatment administration, at the end of treatment, and during safety follow-up, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Apr 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongxia Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647016
- Sponsor's protocol ID
- UNITY Trial
- Status last verified
- Jun 2026
- First submitted
- 13 Dec 2025
- Last updated
- 15 Jun 2026
- 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Single-center Phase II Clinical Study of Deruxtecan in Combination With ivonescImab in Hormone Receptor-positive HER2 Negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07647016
- Acronym / sponsor ID
- UNITY Trial
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 15 Jun 2026 (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 UNITY study is a prospective, single-arm, single-center, Phase II clinical trial conducted by Fudan University Shanghai Cancer Center. It aims to evaluate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) combined with ivonescimab in patients with hormone receptor-positive (HR+), HER2-negative recurrent or metastatic breast cancer.
Approximately 53 patients will be enrolled. Eligible participants must have histologically confirmed advanced HR-positive breast cancer with HER2-low or HER2-ultralow expression. They must have experienced recurrence, metastasis, or disease progression after prior treatment with a CDK4/6 inhibitor (including in the adjuvant setting) and have received at most one line of systemic chemotherapy for advanced disease. The study permits the enrollment of patients with central nervous system (CNS) metastases.
The primary endpoint is the Overall Response Rate (ORR). Key secondary endpoints include Clinical Benefit Rate (CBR), Overall Survival (OS), Progression-Free Survival (PFS), safety, and patient-reported quality of life (assessed using EORTC QLQ-C30 and QLQ-BR23). Exploratory endpoints will involve the analysis of biomarkers from tumor and blood samples, as well as PAM50 molecular subtyping and its correlation with survival outcomes.
This study seeks to explore the efficacy and safety of Trastuzumab Deruxtecan in combination with ivonescimab for patients with HR-positive, HER2-negative recurrent or metastatic breast cancer, with a particular focus on the subpopulation with CNS metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm1 | Experimental | Drug: Trastuzumab Deruxtecan and ivonescimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 18 years, any gender.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Histologically or cytologically confirmed Hormone Receptor-positive (HR+) and Human Epidermal Growth Factor Receptor 2 (HER2)-low or HER2-ultralow breast cancer, with evidence of locally recurrent or metastatic disease that is not amenable to curative-intent surgery or radiation therapy.
- Life expectancy of ≥ 3 months.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Key exclusion criteria (20 listed)
- Confirmed leptomeningeal metastases by Magnetic Resonance Imaging (MRI) or lumbar puncture.
- Prior treatment with anti-PD-1/PD-L1 or anti-VEGF agents, unless both of the following conditions are met: (1) The patient did not experience disease progression during treatment with the anti-PD-1/PD-L1 or anti-VEGF agent; and (2) The time from the last dose of the anti-PD-1/PD-L1 or anti-VEGF agent to the time of recurrence or disease progression is ≥ 3 months.
- Presence of third-space fluid accumulation (e.g., massive pleural or peritoneal effusion) that cannot be controlled by drainage or other methods.
- Receipt of whole-brain radiotherapy, chemotherapy, targeted biologic therapy, immunotherapy, surgery, or endocrine therapy within 2 weeks prior to the first dose of study drug. Bone-modifying agents for the treatment of bone metastases or prevention of osteoporosis are permitted.
- Prior treatment with trastuzumab deruxtecan or any antibody-drug conjugate (ADC) containing a topoisomerase inhibitor.
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 |
|---|---|---|
| Trastuzumab Deruxtecan and ivonescimab* Trastuzumab Deruxtecan (T-DXd): Administered at a dose of 5.4 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle. * Ivonescimab: Administered at a dose of 20 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle. Treatment for both agents will continue until disease progression or unacceptable toxicity. | Drug | Arm1 |
Primary outcome
ORR
Time frame: From treatment initiation until disease progression or death, assessed by RECIST v1.1., assessed up to 24 months
ORR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1 .Time from randomization to disease progression or death, assessed by RECIST v1.1.
6 secondary outcomes
PFS
Time frame: From treatment initiation until disease progression or death, assessed by RECIST v1.1., whichever occurs first, assessed up to 24 months.
OS
Time frame: From treatment initiation until death from any cause, assessed up to 36 months.
Clinical Benefit Rate
Time frame: From treatment initiation until disease progression or death, assessed by RECIST v1.1., whichever occurs first, assessed up to 24 months.
Safety assessed by NCI-CTCAE v5.0
Time frame: From the first dose of study treatment until 30 days after the last dose of study treatment, assessed up to approximately 2 years.
Quality of Life Assessed by EORTC QLQ-C30
Time frame: Screening, within 3 days before each treatment administration, at the end of treatment, and during safety follow-up, assessed up to 24 months.
Breast cancer-specific quality of life assessed by EORTC QLQ-BR45
Time frame: Screening, within 3 days before each treatment administration, at the end of treatment, and during safety follow-up, assessed up to 24 months.
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 15 Jun 2026.
- 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.
Ting Li contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab Deruxtecan and ivonescimab in people with Breast Cancer, run by Fudan University 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 17 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. 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 phase mean?
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?
Contact Hongxia Wang (86-138196379, whx365@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: From treatment initiation until disease progression or death, assessed by RECIST v1.1., assessed up to 24 months). 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 15 Jun 2026.