Breast Cancer FemalesPhase 2NCT07657130
Optimal Application Timing of ADC Drugs for Advanced Breast Cancer
A Phase 2 study testing Antibody drug conjugate and Chemotherapy in people with Breast Cancer Females, run by Liaoning Cancer Hospital & Institute at 1 site in China.
Trial summary
This study plans to initiate a prospective, randomized controlled trial to investigate the optimal timing of antibody drug conjugate (ADC) therapy in the management of advanced Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer Females
- What is being tested?
- Antibody drug conjugate and Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 30 Dec 2026
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18-75 years;
- Histologically confirmed advanced HER2-negative breast cancer, including IHC 2+/ISH-, IHC 1+/ISH-, and IHC 0/ISH- subtypes;
- Completed first-line combination chemotherapy for advanced/metastatic disease (specific regimen not restricted), with disease progression (PD) evaluated per RECIST criteria (HR-positive patients must have received at least one line of endocrine therapy);
- Electrocorticography (ECOG) performance status < 2;
- Estimated life expectancy ≥ 12 weeks;
- Adequate bone marrow function, defined as:
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- ANC ≥ 1.5 × 10⁹/L
- Platelets ≥ 90 × 10⁹/L
- Hemoglobin ≥ 90 g/L
- Adequate hepatic and renal function, defined as:
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- AST or ALT ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases)
- Creatinine clearance ≥ 60 mL/min
- Signed informed consent obtained prior to any study-related procedures or treatments, confirming the patient's willingness to participate and comply with study requirements.
Who cannot join
- Prior treatment with an ADC after disease recurrence or metastasis;
- Pregnant or breastfeeding women;
- No evaluable recurrent or metastatic lesions as defined by RECIST 1.1 criteria;
- Symptomatic brain parenchymal and/or leptomeningeal metastases with symptoms not adequately controlled by treatment;
- History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, cutaneous squamous cell carcinoma, or well-controlled localized basal cell carcinoma of the skin;
- Psychiatric disorders or other conditions that may interfere with patient compliance;
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- Recent history of serious and uncontrolled systemic diseases, such as clinically significant cardiovascular disease, pulmonary disease, metabolic disorders, or arterial/venous thromboembolic events;
- Concurrent use of other investigational drugs, or participation in another clinical trial within 30 days prior to enrollment;
- Known or suspected allergy to any study drug or its excipients;
- Any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning
Liaoning Cancer Hospital & Institute, 86-19800367870, lvdan9303@163.com
About this study
Official title: A Prospective, Randomized Controlled Phase II Trial Investigating the Optimal Timing of Antibody Drug Conjugates in Advanced HER2-Negative Breast Cancer Patients
This study plans to initiate a prospective, randomized controlled trial to investigate the optimal timing of antibody drug conjugate (ADC) therapy in the management of advanced Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer.
Primary Objective:
Read more
To compare the difference in PFS2 (Time from randomization to disease progression after second therapy) between antibody-drug conjugate (ADC) followed by chemotherapy versus chemotherapy followed by ADC in the treatment of advanced HER2-negative breast cancer.
Secondary Objectives:
To compare overall survival (OS), adverse events, patient-reported outcomes, and cost-effectiveness between the two treatment sequences. Additionally, to identify potential biomarkers predictive of benefit from frontline ADC therapy.
- Conditions
- Breast Cancer Females
- Being tested
- Antibody drug conjugate, Chemotherapy
- Keywords
- Breast cancer, Antibody drug conjugate, Timing of application, Randomized controlled trial, HER2-negative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibody drug conjugateDrug
The selection of ADC agents will be based on the patient's molecular subtype. For Hormone receptor (HR)+/HER2-low patients, anti-HER2 ADCs such as trastuzumab deruxtecan may be used. For HR+/HER2-zero patients, TROP-2-targeted ADCs such as sacituzumab govitecan are preferred. For HR-/HER2-low patients, either anti-HER2 ADCs or Trophoblast cell surface antigen 2 (TROP-2) ADCs may be considered. For HR-/HER2-zero patients, TROP-2 ADCs will be used. The specific ADC regimen will be determined at the discretion of the investigators.
ChemotherapyDrug
The chemotherapy regimen will consist of standard second-line agents such as capecitabine, eribulin, vinorelbine, or gemcitabine. The specific chemotherapy regimen will be determined at the discretion of the investigators.
| Study group | Role | What they receive |
|---|---|---|
| ADC followed by chemotherapy group | Experimental | Patients will receive an ADC agent as second-line treatment until disease progression or unacceptable toxicity, followed by physician's choice of chemotherapy as third-line treatment Receives: Drug: Antibody drug conjugate; Drug: Chemotherapy |
| Chemotherapy followed by ADC group | Active comparator | Patients will receive physician's choice of chemotherapy as second-line treatment until disease progression or unacceptable toxicity, followed by an ADC agent as third-line treatment. Receives: Drug: Antibody drug conjugate; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival 2 (PFS2)
Progression-free survival 2 (PFS2) is defined as the time from randomization to disease progression or death (whichever occurs first) following the second treatment.
Measured: Up to approximately 20 months
Secondary outcomes (4)
Overall Survival (OS)
Defined as the time from randomization to death from any cause.
Measured: Up to approximately 40 months
Patient-Reported Outcomes (PROs)
Defined as reports directly from patients regarding their health status, functional status, and treatment experience during the period from randomization to disease progression, without interpretation by clinicians or others.
Measured: Up to approximately 20 months
Time to Progression (TTP)
Defined as the time from randomization to disease progression.
Measured: Up to approximately 20 months
Adverse event
Defined as the occurrence of adverse events after enrollment, evaluated according to NCI CTCAE version 5.0.
Measured: Up to approximately 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Jul 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemalesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaoning Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Center, China
- Responsible party
- Principal investigator, Tao Sun, Liaoning Cancer Hospital & Institute
- Investigators
- Tao Sun, Principal investigator, Liaoning Cancer Hospital & InstituteBo Lan, Principal investigator, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657130
- Sponsor's protocol ID
- OPTIMA-BC
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 18 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Phase II Trial Investigating the Optimal Timing of Antibody Drug Conjugates in Advanced HER2-Negative Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07657130
- Acronym / sponsor ID
- OPTIMA-BC
- Conditions
- Breast Cancer Females
- Keywords
- Breast cancer, Antibody drug conjugate, Timing of application, Randomized controlled trial, HER2-negative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Liaoning Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- National Cancer Center, China
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 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.
This study plans to initiate a prospective, randomized controlled trial to investigate the optimal timing of antibody drug conjugate (ADC) therapy in the management of advanced Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer.
Primary Objective:
To compare the difference in PFS2 (Time from randomization to disease progression after second therapy) between antibody-drug conjugate (ADC) followed by chemotherapy versus chemotherapy followed by ADC in the treatment of advanced HER2-negative breast cancer.
Secondary Objectives:
To compare overall survival (OS), adverse events, patient-reported outcomes, and cost-effectiveness between the two treatment sequences. Additionally, to identify potential biomarkers predictive of benefit from frontline ADC therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADC followed by chemotherapy group | Experimental | Drug: Antibody drug conjugate, Drug: ChemotherapyPatients will receive an ADC agent as second-line treatment until disease progression or unacceptable toxicity, followed by physician's choice of chemotherapy as third-line treatment |
| Chemotherapy followed by ADC group | Active comparator | Drug: Antibody drug conjugate, Drug: ChemotherapyPatients will receive physician's choice of chemotherapy as second-line treatment until disease progression or unacceptable toxicity, followed by an ADC agent as third-line treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Female patients aged 18-75 years;
- Histologically confirmed advanced HER2-negative breast cancer, including IHC 2+/ISH-, IHC 1+/ISH-, and IHC 0/ISH- subtypes;
- Completed first-line combination chemotherapy for advanced/metastatic disease (specific regimen not restricted), with disease progression (PD) evaluated per RECIST criteria (HR-positive patients must have received at least one line of endocrine therapy);
- Electrocorticography (ECOG) performance status < 2;
- Estimated life expectancy ≥ 12 weeks;
Key exclusion criteria (10 listed)
- Prior treatment with an ADC after disease recurrence or metastasis;
- Pregnant or breastfeeding women;
- No evaluable recurrent or metastatic lesions as defined by RECIST 1.1 criteria;
- Symptomatic brain parenchymal and/or leptomeningeal metastases with symptoms not adequately controlled by treatment;
- History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, cutaneous squamous cell carcinoma, or well-controlled localized basal cell carcinoma of the skin;
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 |
|---|---|---|
| Antibody drug conjugateThe selection of ADC agents will be based on the patient's molecular subtype. For Hormone receptor (HR)+/HER2-low patients, anti-HER2 ADCs such as trastuzumab deruxtecan may be used. For HR+/HER2-zero patients, TROP-2-targeted ADCs such as sacituzumab govitecan are preferred. For HR-/HER2-low patients, either anti-HER2 ADCs or Trophoblast cell surface antigen 2 (TROP-2) ADCs may be considered. For HR-/HER2-zero patients, TROP-2 ADCs will be used. The specific ADC regimen will be determined at the discretion of the investigators. | Drug | ADC followed by chemotherapy group, Chemotherapy followed by ADC group |
| ChemotherapyThe chemotherapy regimen will consist of standard second-line agents such as capecitabine, eribulin, vinorelbine, or gemcitabine. The specific chemotherapy regimen will be determined at the discretion of the investigators. | Drug | ADC followed by chemotherapy group, Chemotherapy followed by ADC group |
Primary outcome
Progression-free survival 2 (PFS2)
Time frame: Up to approximately 20 months
Progression-free survival 2 (PFS2) is defined as the time from randomization to disease progression or death (whichever occurs first) following the second treatment.
4 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 40 months
Patient-Reported Outcomes (PROs)
Time frame: Up to approximately 20 months
Time to Progression (TTP)
Time frame: Up to approximately 20 months
Adverse event
Time frame: Up to approximately 20 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 18 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.
Tao Sun principal investigator
Liaoning Cancer Hospital & Institute
Bo Lan principal investigator
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
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 Antibody drug conjugate and Chemotherapy in people with Breast Cancer Females, run by Liaoning Cancer Hospital & Institute 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 14 inclusion and 10 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 18 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 Dan Lyu (0086-19800367870, lvdan9303@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival 2 (PFS2) (time frame: Up to approximately 20 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 18 Jun 2026.