Breast CancerPhase 1NCT06331169
Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer
A Phase 1 study testing Anlotinib and Trastuzumab deruxtecan in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This study will evaluate the safety, tolerability and efficacy of anlotinib and trastuzumab deruxtecan in human epidermal growth factor receptor 2 (HER2)-low unresectable and/or metastatic breast cancer who had received ≤1 line of prior chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Anlotinib and Trastuzumab deruxtecan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2024to 30 Jun 2027
- Phase
- Phase 1
- 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
- 1. Age 18 - 75 years; ECOG PS 0 or 1. 2. Pathologically documented breast cancer that:
- Is unresectable or metastatic.
- Has a history of low HER2 expression (IHC 1+\& IHC 2+/ISH- or 0<IHC<1+).
- Is HR-positive or HR-negative.
- Has progressed on, and would no longer benefit from, endocrine therapy.
- Has been treated with ≥1 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting.
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- 3. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1（Previously treated lesions with radiotherapy or focal therapy and no progression cannot be included as target lesion for assessment）.
- 4. Has protocol-defined adequate bone marrow, renal, hepatic and blood clotting functions.
- 5. Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and after the last dose for at least 6 months.
Who cannot join
- Has previously been treated with anti-angiogenic targeted small molecule therapy.
- Prior treatment with antibody drug conjugate with a topoisomerase I inhibitor exatecan derivative.
- Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Has unresolved toxicities from previous anticancer therapy.
- Has uncontrolled or significant cardiovascular disease.
- Has any bleeding event, unhealed wounds, ulcerative or fractures.
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- Has arterial or venous thromboembolic events occurred within 6 months.
- Has spinal cord compression or clinically active central nervous system metastases.
- Has any other condition that per protocol or in the opinion of the investigator is inappropriate for the study.
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
Jian Zhang
Shanghai, Shanghai Municipality, 200433
Jian Zhang, MD,PhD, +8664175590 ext. 85000, syner2000@163.com
About this study
Official title: A Prospective Phase Ib Study of Anlotinib With Trastuzumab Deruxtecan for HER2-Low Unresectable and/or Metastatic Breast Cancer (ALTER-BC-Ib-01)
This study will evaluate the safety, tolerability and efficacy of anlotinib and trastuzumab deruxtecan in human epidermal growth factor receptor 2 (HER2)-low unresectable and/or metastatic breast cancer who had received ≤1 line of prior chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- Anlotinib, Trastuzumab deruxtecan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
Also called Anlotinib dihydrochloride
Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit.
Trastuzumab deruxtecanDrug
Also called DS-8201
Trastuzumab deruxtecan is an antibody-drug conjugate composed of an anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable tetrapeptide-based linker, and a cytotoxic topoisomerase I inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib dose escalation + trastuzumab deruxtecan | Experimental | Various doses of anlotinib (8 mg QD, 10 mg QD, and 12 mg QD) administered during dose escalation to determine the recommended phase 2 Dose (RP2D) + trastuzumab deruxtecan 5.4 mg/kg.
Anlotinib at the RP2D + trastuzumab deruxtecan 5.4 mg/kg combination therapy Receives: Drug: Anlotinib; Drug: Trastuzumab deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the RP2D of anlotinib in combination with trastuzumab deruxtecan
The RP2D is defined as the dose level for the dose expansion phase, based on safety, tolerability, efficacy collected during the dose escalation portion of the study.
Measured: up to 1 year
Objective Response Rate (ORR)
ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: Up to approximately 3 years
Secondary outcomes (5)
Duration of Response (DCR)
DCR is defined as the percentage of cases with remission (PR+CR) and stable disease (SD) after treatment in the evaluable cases.
Measured: Up to approximately 3 years
Duration of Response (DOR)
DOR is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.
Measured: Up to approximately 3 years
Progression-free Survival (PFS)
PFS is defined as the time from the participant's first dose of study treatment to the first date of either disease progression or death, whichever occurs first.
Measured: Up to approximately 3 years
Overall Survival (OS)
OS is defined as the time from the participant's first dose of study treatment to the date of death.
Measured: Up to approximately 3 years
Number of Participants With Adverse Events (AEs)
Assessment of the toxicity profile of regimen according to the National Cancer Institute Common Toxicity Criteria version 5.0 (NCI CTCAE v 5.0).
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start31 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331169
- Sponsor's protocol ID
- ALTER-BC-Ib-01
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase Ib Study of Anlotinib With Trastuzumab Deruxtecan for HER2-Low Unresectable and/or Metastatic Breast Cancer (ALTER-BC-Ib-01)
- ClinicalTrials.gov ID
- NCT06331169
- Acronym / sponsor ID
- ALTER-BC-Ib-01
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 Mar 2024 (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 will evaluate the safety, tolerability and efficacy of anlotinib and trastuzumab deruxtecan in human epidermal growth factor receptor 2 (HER2)-low unresectable and/or metastatic breast cancer who had received ≤1 line of prior chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib dose escalation + trastuzumab deruxtecan | Experimental | Drug: Anlotinib, Drug: Trastuzumab deruxtecanVarious doses of anlotinib (8 mg QD, 10 mg QD, and 12 mg QD) administered during dose escalation to determine the recommended phase 2 Dose (RP2D) + trastuzumab deruxtecan 5.4 mg/kg. Anlotinib at the RP2D + trastuzumab deruxtecan 5.4 mg/kg combination therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Age 18 - 75 years; ECOG PS 0 or 1. 2. Pathologically documented breast cancer that:
- 3. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1（Previously treated lesions with radiotherapy or focal therapy and no progression cannot be included as target lesion for assessment）.
- 4. Has protocol-defined adequate bone marrow, renal, hepatic and blood clotting functions.
- 5. Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and after the last dose for at least 6 months.
Key exclusion criteria (9 listed)
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 |
|---|---|---|
| AnlotinibAlso: Anlotinib dihydrochlorideAnlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit. | Drug | Anlotinib dose escalation + trastuzumab deruxtecan |
| Trastuzumab deruxtecanAlso: DS-8201Trastuzumab deruxtecan is an antibody-drug conjugate composed of an anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable tetrapeptide-based linker, and a cytotoxic topoisomerase I inhibitor. | Drug | Anlotinib dose escalation + trastuzumab deruxtecan |
Primary outcome
Determination of the RP2D of anlotinib in combination with trastuzumab deruxtecan
Time frame: up to 1 year
The RP2D is defined as the dose level for the dose expansion phase, based on safety, tolerability, efficacy collected during the dose escalation portion of the study.
Objective Response Rate (ORR)
Time frame: Up to approximately 3 years
ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
5 secondary outcomes
Duration of Response (DCR)
Time frame: Up to approximately 3 years
Duration of Response (DOR)
Time frame: Up to approximately 3 years
Progression-free Survival (PFS)
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time frame: Up to approximately 3 years
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 3 years
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 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anlotinib and Trastuzumab deruxtecan 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 9 inclusion and 9 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 30 Aug 2024. 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 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the RP2D of anlotinib in combination with trastuzumab deruxtecan (time frame: up to 1 year). The study lists 2 primary outcomes in all. 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 Aug 2024.