Breast NeoplasmsPhase 2NCT07907354
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
A Phase 2 study testing Apatinib mesylate and Physician's choice chemotherapy in people with Breast Neoplasms and Advanced Breast Cancer, run by Yunnan Cancer Hospital.
Trial summary
This is a single-arm, open-label, phase 2 clinical trial using a stratified Simon minimax two-stage design. The study aims to evaluate the efficacy and safety of low-dose apatinib (250 mg daily) combined with physician-selected single-agent chemotherapy (TPC, capecitabine preferred) in patients with HER2-positive or… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms, Advanced Breast Cancer, HER2-positive Breast Cancer
- What is being tested?
- Apatinib mesylate and Physician's choice chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2027to 30 Jun 2030
- 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
- Written informed consent obtained before any study procedures.
- Age ≥ 18 years.
- Histologically confirmed diagnosis of advanced breast cancer (ABC) or metastatic breast cancer (MBC).
- HER2 status confirmed by local or central laboratory: either HER2-positive (IHC 3+ or ISH+) OR HER2-low (IHC 1+ or IHC 2+/ISH-).
- Disease progression after at least one cycle of prior antibody-drug conjugate (ADC) therapy (e.g., trastuzumab deruxtecan [T-DXd], SHR-A1811, or other HER2-directed ADC).
- For hormone receptor-positive (HR+) patients, prior treatment with CDK4/6 inhibitor is required.
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- At least one measurable lesion as defined by RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (or 0-2 per protocol).
- Adequate organ function including: absolute neutrophil count ≥ 1.5 × 10^9/L, platelets ≥ 100 × 10^9/L, hemoglobin ≥ 90 g/L; total bilirubin ≤ 1.5 × ULN; ALT/AST ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases); serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min.
- Expected survival ≥ 3 months.
- Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception; male patients with partners of childbearing potential must agree to use effective contraception.
Who cannot join
- Known hypersensitivity to apatinib mesylate, capecitabine, or other study chemotherapy agents.
- Uncontrolled hypertension defined as systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg despite optimal antihypertensive therapy.
- History of severe cardiovascular disease within 6 months prior to enrollment, including myocardial infarction, unstable angina, coronary artery bypass graft, stroke, or New York Heart Association (NYHA) Class III/IV heart failure.
- Active bleeding, coagulation disorders, or requirement for therapeutic anticoagulation with warfarin or direct oral anticoagulants (low-dose prophylactic anticoagulation allowed).
- Unhealed surgical wounds, active peptic ulcer, or gastrointestinal perforation/fistula within 6 months.
- Untreated or progressive central nervous system (CNS) metastases (patients with stable, treated brain metastases who have discontinued corticosteroids for ≥ 2 weeks may be eligible per investigator discretion).
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- History of interstitial lung disease (ILD), current ILD, or pneumonitis requiring steroids.
- Pregnant or breastfeeding women.
- Other active malignancies within 3 years prior to enrollment (except cured basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ of cervix).
- Concomitant use of strong CYP3A4 inhibitors or inducers that cannot be safely interrupted.
- Any other condition that, in the investigator's judgment, would make the patient inappropriate for study participation or unable to comply with study procedures.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm, Stratified Two-Stage Phase II Study of Low-Dose Apatinib Plus Physician's Choice Monotherapy Chemotherapy (TPC) in Patients With HER2-Positive and HER2-Low Advanced Breast Cancer After Progression on Antibody-Drug Conjugate Therapy
This is a single-arm, open-label, phase 2 clinical trial using a stratified Simon minimax two-stage design. The study aims to evaluate the efficacy and safety of low-dose apatinib (250 mg daily) combined with physician-selected single-agent chemotherapy (TPC, capecitabine preferred) in patients with HER2-positive or HER2-low advanced/metastatic breast cancer who progressed after prior ADC therapy (T-DXd or SHR-A1811). Patients are stratified by HER2 status, HR status, lines of prior ADC therapy, and metastasis sites. Approximately 56 patients will be enrolled. The primary endpoint is objective response rate (ORR). Secondary endpoints include PFS1, PFS2, TTP, safety, and OS.
- Conditions
- Breast Neoplasms, Advanced Breast Cancer, HER2-positive Breast Cancer, HER2-low Breast Cancer
- Being tested
- Apatinib mesylate, Physician's choice chemotherapy
- Keywords
- Apatinib, Antibody-drug conjugate, VEGFR2 inhibitor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib mesylateDrug
Also called Low-dose apatinib
Apatinib mesylate tablets, 250 mg, orally, once daily (QD). Dose modifications (interruption, reduction to 250 mg every other day or 3 days on/4 days off) are allowed per protocol for the management of adverse events (e.g., hypertension, proteinuria, hand-foot syndrome, diarrhea).
Physician's choice chemotherapyDrug
Single-agent chemotherapy selected by the investigator from a pre-specified list, based on patient's prior treatment history (e.g., prior progression on 8201a or A1811), performance status, and investigator judgment. Oral or intravenous administration is allowed.
Permitted agents and their cycles:
- Capecitabine: 1000-1250 mg/m² PO BID, days 1-14, repeat every 21 days
- Vinorelbine: 25 mg/m² IV, days 1/8/15, repeat every 28 days
- Paclitaxel: 80 mg/m² IV, days 1/8/15, repeat every 28 days (or 175 mg/m² IV day 1, repeat every 21 days per investigator choice)
| Study group | Role | What they receive |
|---|---|---|
| Apatinib + Physician's Choice Chemotherapy | Experimental | Low-dose apatinib mesylate (250 mg orally once daily) combined with physician's choice single-agent chemotherapy (TPC). TPC is selected by investigator based on prior therapy, with XLD (capecitabine, vinorelbine, taxane, etc.) as priority. Treatment continues until disease progression or unacceptable toxicity. Receives: Drug: Apatinib mesylate; Drug: Physician's choice chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is defined as the proportion of participants with a Complete Response (CR) or Partial Response (PR) as assessed by the investigator according to RECIST v1.1. Response confirmation is not required.
Measured: every 2 cycles (each cycle is 21 or 28 days depending on chosen chemotherapy)， up to disease progression or 24 months
Secondary outcomes (5)
Progression-Free Survival
PFS is defined as the time from treatment initiation to the date of first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Measured: From treatment initiation to disease progression or death, assessed every 2 cycles(each cycle is 21 or 28 days depending on chosen chemotherapy)
Time to Progression (TTP)
Time from first dose to first documented disease progression.
Measured: From treatment initiation to first progression, assessed every 2 cycles ( each cycle is 21 or 28 days depending on chosen chemotherapy), up to approximately 24 months
Overall Survival (OS)
OS is defined as the time from treatment initiation to the date of death from any cause. Participants alive at last follow-up will be censored.
Measured: From treatment initiation to death from any cause (up to 36 months)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Safety will be assessed by the incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs). AEs will be graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory abnormalities, vital signs, and ECG changes will also be evaluated.
Measured: Baseline through end of treatment and 30-day follow-up (each cycle is 21 or 28 days depending on chosen chemotherapy)
Clinical Benefit Rate (CBR)
Proportion of patients achieving CR, PR, or stable disease (SD) lasting ≥ 6 months as per RECIST 1.1.
Measured: Every 2 cycles（each cycle is 21 or 28 days depending on chosen chemotherapy） 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 posted30 Oct 2026
- Study start1 Mar 2027 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, stratified two-stage Simon minimax design; approximately 56 participants stratified by HER2 status (HER2-positive and HER2-low)
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunnan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nie Jianyun, Yunnan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907354
- Sponsor's protocol ID
- POST-ADC-01
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 30 Oct 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Stratified Two-Stage Phase II Study of Low-Dose Apatinib Plus Physician's Choice Monotherapy Chemotherapy (TPC) in Patients With HER2-Positive and HER2-Low Advanced Breast Cancer After Progression on Antibody-Drug Conjugate Therapy
- ClinicalTrials.gov ID
- NCT07907354
- Acronym / sponsor ID
- POST-ADC-01
- Conditions
- Breast Neoplasms, Advanced Breast Cancer, HER2-positive Breast Cancer, HER2-low Breast Cancer
- Keywords
- Apatinib, Antibody-drug conjugate, VEGFR2 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Yunnan Cancer HospitalUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 30 Oct 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 is a single-arm, open-label, phase 2 clinical trial using a stratified Simon minimax two-stage design. The study aims to evaluate the efficacy and safety of low-dose apatinib (250 mg daily) combined with physician-selected single-agent chemotherapy (TPC, capecitabine preferred) in patients with HER2-positive or HER2-low advanced/metastatic breast cancer who progressed after prior ADC therapy (T-DXd or SHR-A1811). Patients are stratified by HER2 status, HR status, lines of prior ADC therapy, and metastasis sites. Approximately 56 patients will be enrolled. The primary endpoint is objective response rate (ORR). Secondary endpoints include PFS1, PFS2, TTP, safety, and OS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, stratified two-stage Simon minimax design; approximately 56 participants stratified by HER2 status (HER2-positive and HER2-low)
| Arm | Type | Receives |
|---|---|---|
| Apatinib + Physician's Choice Chemotherapy | Experimental | Drug: Apatinib mesylate, Drug: Physician's choice chemotherapyLow-dose apatinib mesylate (250 mg orally once daily) combined with physician's choice single-agent chemotherapy (TPC). TPC is selected by investigator based on prior therapy, with XLD (capecitabine, vinorelbine, taxane, etc.) as priority. Treatment continues until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent obtained before any study procedures.
- Age ≥ 18 years.
- Histologically confirmed diagnosis of advanced breast cancer (ABC) or metastatic breast cancer (MBC).
- HER2 status confirmed by local or central laboratory: either HER2-positive (IHC 3+ or ISH+) OR HER2-low (IHC 1+ or IHC 2+/ISH-).
- Disease progression after at least one cycle of prior antibody-drug conjugate (ADC) therapy (e.g., trastuzumab deruxtecan [T-DXd], SHR-A1811, or other HER2-directed ADC).
Key exclusion criteria (11 listed)
- Known hypersensitivity to apatinib mesylate, capecitabine, or other study chemotherapy agents.
- Uncontrolled hypertension defined as systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg despite optimal antihypertensive therapy.
- History of severe cardiovascular disease within 6 months prior to enrollment, including myocardial infarction, unstable angina, coronary artery bypass graft, stroke, or New York Heart Association (NYHA) Class III/IV heart failure.
- Active bleeding, coagulation disorders, or requirement for therapeutic anticoagulation with warfarin or direct oral anticoagulants (low-dose prophylactic anticoagulation allowed).
- Unhealed surgical wounds, active peptic ulcer, or gastrointestinal perforation/fistula within 6 months.
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 |
|---|---|---|
| Apatinib mesylateAlso: Low-dose apatinibApatinib mesylate tablets, 250 mg, orally, once daily (QD). Dose modifications (interruption, reduction to 250 mg every other day or 3 days on/4 days off) are allowed per protocol for the management of adverse events (e.g., hypertension, proteinuria, hand-foot syndrome, diarrhea). | Drug | Apatinib + Physician's Choice Chemotherapy |
| Physician's choice chemotherapySingle-agent chemotherapy selected by the investigator from a pre-specified list, based on patient's prior treatment history (e.g., prior progression on 8201a or A1811), performance status, and investigator judgment. Oral or intravenous administration is allowed. Permitted agents and their cycles: * Capecitabine: 1000-1250 mg/m² PO BID, days 1-14, repeat every 21 days * Vinorelbine: 25 mg/m² IV, days 1/8/15, repeat every 28 days * Paclitaxel: 80 mg/m² IV, days 1/8/15, repeat every 28 days (or 175 mg/m² IV day 1, repeat every 21 days per investigator choice) | Drug | Apatinib + Physician's Choice Chemotherapy |
Primary outcome
Objective Response Rate (ORR)
Time frame: every 2 cycles (each cycle is 21 or 28 days depending on chosen chemotherapy)， up to disease progression or 24 months
ORR is defined as the proportion of participants with a Complete Response (CR) or Partial Response (PR) as assessed by the investigator according to RECIST v1.1. Response confirmation is not required.
5 secondary outcomes
Progression-Free Survival
Time frame: From treatment initiation to disease progression or death, assessed every 2 cycles(each cycle is 21 or 28 days depending on chosen chemotherapy)
Time to Progression (TTP)
Time frame: From treatment initiation to first progression, assessed every 2 cycles ( each cycle is 21 or 28 days depending on chosen chemotherapy), up to approximately 24 months
Overall Survival (OS)
Time frame: From treatment initiation to death from any cause (up to 36 months)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: Baseline through end of treatment and 30-day follow-up (each cycle is 21 or 28 days depending on chosen chemotherapy)
Clinical Benefit Rate (CBR)
Time frame: Every 2 cycles（each cycle is 21 or 28 days depending on chosen chemotherapy） 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 30 Oct 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib mesylate and Physician's choice chemotherapy in people with Breast Neoplasms and Advanced Breast Cancer, run by Yunnan Cancer Hospital.
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 11 inclusion and 11 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 NIe J yun (086-13658801886, sammer312@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: every 2 cycles (each cycle is 21 or 28 days depending on chosen chemotherapy)， up to disease progression or 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 30 Oct 2026.