Metastatic Breast CancerPhase 2NCT04001621
Pyrotinib in Combination With Capecitabine in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer
A Phase 2 study testing Pyrotinib combined with capecitabine in people with Metastatic Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Trastuzumab resistance, which is a common therapeutic challenge in HER2 positive metastatic breast cancer, is not fully understood. Pyrotinib is an oral tyrosine kinase inhibitor targeting EGFR, HER-2 and HER-4 receptors. More general inhibition of ErbB family with pyrotinib could provide additional benefit. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Pyrotinib combined with capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2019to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed HER2 positive patients with locally advanced or metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification
- Aged ≥18 and ≤70 years.
- ECOG performance status of 0 to 1.
- Life expectancy of more than 12 weeks;
- At least one measurable lesion exists(RECIST 1.1)
- Patients with trastuzumab resistance is defined as follows:
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- Progression during or within 12 months after treatment in neoadjuvant or adjuvant setting (at least 9 weeks of trastuzumab treatment); Or Progression during or within 6 months after treatment for locally advanced or metastatic disease in the first-line setting (at least 6 weeks of trastuzumab treatment).
- At least 4 weeks from the last treatment of trastuzumab or chemotherapy，at least 5 times of t1/2 or 4 weeks from the last treatment of endocrine therapy（the shorter one is preferred）
- Known hormone receptor status
- For patients with brain metastases, local treatment (including whole cranial radiotherapy, SBRT, etc.) is required and the brain lesions are stable for ≥ 3 months without the need for dexamethasone or mannitol treatment
- Patients with adequate organ function before enrollment:
- ANC≥1.5×10^9/L
- PLT≥100×10^9/L
- Hb≥90 g/L
- TBIL≤1.5×ULN
- ALT and AST≤3×ULN, （ALT and AST≤5×ULN in patients with liver metastases）
- Cr≤1.5×ULN and the creatinine clearance rate≥50 mL/min
- LVEF ≥ 50%
- QTcF < 480 ms
- Signed informed consent.
Who cannot join
- Patients with meningeal metastasis and / or spinal cord metastasis;
- Patients unable to swallow, with chronic diarrhea, intestinal obstruction, or multiple factors that affect drug use and absorption;
- Patients with malignant serious effusion which cannot be controlled by drainage or other methods;
- Less than 4 weeks from the last treatment in last clinical trial;
- Known dihydropyrimidine dehydrogenase (DPD) deficiency;
- Receiving any other antitumor therapy;
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- History of other malignancy within the last 5 years, except for carcinoma in situ of cervix, basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent;
- Received radiotherapy, surgery (excluding local puncture) within 4 weeks prior to enrollment; received anti-tumor endocrine therapy after entering the screening period;
- Previous or ongoing use of HER2-targeted tyrosine kinase inhibitors (lapatinib, neratinib or pyrotinib);
- Previous use of capecitabine or capecitabine not tolerated, except that capecitabine efficacy cannot be judged or capecitabine discontinuation for 3 months or more;
- Patients with serious heart disease;
- Allergy to pyrotinib; history of immunodeficiency, including HIV positive, active HBV/HCV or other acquired, congenital immunodeficiency disease, or organ transplantation history;
- Known history of neurological or psychiatric disease, including epilepsy or dementia;
- Patients during pregnancy or lactation, patients with childbearing potential tested positive in baseline pregnancy test, or patients unwilling to take effective contraceptive measures throughout the trial;
- Evidence of significant medical illness that will substantially increase the risk on the participation or completion of the study in the investigator's judgment. Examples included, but not limited to, hypertension, severe diabetes, etc;
- Patients not eligible for this study judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Pyrotinib in Combination With Capecitabine in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer
Trastuzumab resistance, which is a common therapeutic challenge in HER2 positive metastatic breast cancer, is not fully understood. Pyrotinib is an oral tyrosine kinase inhibitor targeting EGFR, HER-2 and HER-4 receptors. More general inhibition of ErbB family with pyrotinib could provide additional benefit. This study is designed to evaluate the efficacy and safety of pyrotinib in combination with capecitabine in patients with HER2 positive locally advanced or metastatic breast cancer who had early failure on or after trastuzumab treatment.
Read the detailed description
A multi-center, one-arm, open label design study, which is planned to enroll 100 patients with trastuzumab-resistant HER2-positive advanced breast cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Pyrotinib combined with capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrotinib combined with capecitabineDrug
pyrotinib 400 mg once daily; Capecitabine 1000 mg/m2 per day on day 1 through 14, every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib plus capecitabine | Experimental | pyrotinib(400 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID) Receives: Drug: Pyrotinib combined with capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
From enrollment to progression or death (for any reason)
Measured: Estimated 12 months
Secondary outcomes (5)
Objective Response Rate (ORR)
Ratio of CR and PR in all subjects
Measured: Estimated 12 months
Duration of Response (DOR)
The first evaluation of CR or PR to progression or death (for any reason)
Measured: Estimated 12 months
Clinical Benefit rate (CBR)
Ratio of CR,PR and SD greater than or equal to 24 weeks in all subjects
Measured: Estimated 12 months
Overall Survival (OS)
From enrollment to death (for any reason)
Measured: Estimated 24 months
Adverse Events and Serious Adverse Events
Safety
Measured: From informed consent through 28 days following treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start26 Jun 2019
- Primary completion31 May 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichun Hu, Fudan University
- Investigators
- Xichun Hu, Principal investigator, Department of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001621
- Sponsor's protocol ID
- HR-BLTN-003
- Status last verified
- Dec 2022
- First submitted
- 27 Jun 2019
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cao J, Teng Y, Li H, Zhang L, Ouyang Q, Xie W, Pan Y, Song Z, Ling X, Wu X, Xu J, Li L, Ren L, Wang H, Zhou D, Luo J, Hu X. Pyrotinib plus capecitabine for trastuzumab-resistant, HER2-positive advanced breast cancer (PICTURE): a single-arm, multicenter phase 2 trial. BMC Med. 2023 Aug 9;21(1):300. doi: 10.1186/s12916-023-02999-0.
PubMed 37559142
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Pyrotinib in Combination With Capecitabine in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT04001621
- Acronym / sponsor ID
- HR-BLTN-003
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Jun 2019 (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.
Trastuzumab resistance, which is a common therapeutic challenge in HER2 positive metastatic breast cancer, is not fully understood. Pyrotinib is an oral tyrosine kinase inhibitor targeting EGFR, HER-2 and HER-4 receptors. More general inhibition of ErbB family with pyrotinib could provide additional benefit. This study is designed to evaluate the efficacy and safety of pyrotinib in combination with capecitabine in patients with HER2 positive locally advanced or metastatic breast cancer who had early failure on or after trastuzumab treatment.
Detailed description
A multi-center, one-arm, open label design study, which is planned to enroll 100 patients with trastuzumab-resistant HER2-positive advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib plus capecitabine | Experimental | Drug: Pyrotinib combined with capecitabinepyrotinib(400 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Pathologically confirmed HER2 positive patients with locally advanced or metastatic breast cancer: HER2 IHC 3+, or HER2 IHC 2+ and FISH detection gene amplification
- Aged ≥18 and ≤70 years.
- ECOG performance status of 0 to 1.
- Life expectancy of more than 12 weeks;
- At least one measurable lesion exists(RECIST 1.1)
Key exclusion criteria (16 listed)
- Patients with meningeal metastasis and / or spinal cord metastasis;
- Patients unable to swallow, with chronic diarrhea, intestinal obstruction, or multiple factors that affect drug use and absorption;
- Patients with malignant serious effusion which cannot be controlled by drainage or other methods;
- Less than 4 weeks from the last treatment in last clinical trial;
- Known dihydropyrimidine dehydrogenase (DPD) deficiency;
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 |
|---|---|---|
| Pyrotinib combined with capecitabinepyrotinib 400 mg once daily; Capecitabine 1000 mg/m2 per day on day 1 through 14, every 21 days. | Drug | Pyrotinib plus capecitabine |
Primary outcome
Progression Free Survival (PFS)
Time frame: Estimated 12 months
From enrollment to progression or death (for any reason)
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: Estimated 12 months
Duration of Response (DOR)
Time frame: Estimated 12 months
Clinical Benefit rate (CBR)
Time frame: Estimated 12 months
Overall Survival (OS)
Time frame: Estimated 24 months
Adverse Events and Serious Adverse Events
Time frame: From informed consent through 28 days following treatment completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Derived from this study: PubMed 37559142Cao J, Teng Y, Li H, Zhang L, Ouyang Q, Xie W, Pan Y, Song Z, Ling X, Wu X, Xu J, Li L, Ren L, Wang H, Zhou D, Luo J, Hu X. Pyrotinib plus capecitabine for trastuzumab-resistant, HER2-positive advanced breast cancer (PICTURE): a single-arm, multicenter phase 2 trial. BMC Med. 2023 Aug 9;21(1):300. doi: 10.1186/s12916-023-02999-0.
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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. This study is not recruiting at the moment.
Xichun Hu principal investigator
Department of Oncology
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 Pyrotinib combined with capecitabine in people with Metastatic 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 20 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 8 Dec 2022. 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?
Results are not available in the source record.
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?
Progression Free Survival (PFS) (time frame: Estimated 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04001621, which also lists 1 linked publication.
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 8 Dec 2022.