Breast CancerPhase 2NCT04236310
A Study of Neoadjuvant SHR6390 in Combination With Anastrozole, Pyrotinib, and Trastuzumab in Patients With ER+/HER2+ Breast Cancer.
A Phase 2 study testing SHR6390, Anastrozole and Pyrotinib in people with Breast Cancer and HER2-positive Breast Cancer, run by Ruijin Hospital.
Trial summary
To evaluate the efficacy and safety of the SHR6390 in combination with anastrozole, pyrotinib, and trastuzumab in patients with ER-positive, HER2-positive breast cancer in the neoadjuvant setting. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, HER2-positive Breast Cancer, ER-positive Breast Cancer
- What is being tested?
- SHR6390, Anastrozole and Pyrotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2020to 31 Dec 2022
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures.
- Age at diagnosis ≥18 years and ≤75 years, female.
- Histologically confirmed diagnosis of Unilateral ER+/HER2+ breast cancer. ER-positivity is defined as >1% stained cells；HER2-positivity is defined as IHC 3+ or if IHC scored 2+, in-situ hybridisation (ISH) suggests amplified HER2 gene.
- Tumor diameter >2 centimeters with the clinical stage being classified as from IIa to IIIc.
- ECOG ≤ 1, LVEF ≥ 55%.
- Laboratory requirements: for hematology, absolute neutrophil count (ANC) ≥1.5 × 109 / L and platelets ≥100 × 109 / L and hemoglobin ≥90 g/L; for hepatic function, total bilirubin ≤1.5 × UNL, AST and ALT ≤2.5 × UNL; for renal function, SCr ≤1.5 × UNL.
Who cannot join
- Evidence of bilateral invasive breast cancer or metastatic disease (M1).
- Pevious treatment with chemotherapy, hormonal therapy, an investigational drug for any type of malignancy, or radiation therapy.
- Any of the following exist in the last 6 months: known or suspected congestive heart failure (≥ NYHA II), persistent arrhythmias (≥ grade 2), atrial fibrillation of any grade, coronary / peripheral bypass, symptomatic congestive heart failure, cerebrovascular accidents (including transient cerebral hemorrhage attacks or symptomatic pulmonary embolism).
- Known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol.
- Active infection or severe symptomatic visceral disease in the last 4 weeks.
- Patients with HIV infection or known AIDS, or patients with infection of active hepatitis B (HBV DNA ≥1000IU / ml) or hepatitis C (hepatitis C antibody is positive and HCV RNA is above the lower limit of detection of the analytical method).
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- Prior malignancy with a disease-free survival of < 5 years, except curatively treated basalioma of the skin, pTis of the cervix uteri.
- Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.
- Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.
- Not eligible for the trial assessed by the investigators of our study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Study of Neoadjuvant SHR6390 in Combination With Anastrozole, Pyrotinib, and Trastuzumab in Patients With ER-Positive, HER2-Positive Breast Cancer.
To evaluate the efficacy and safety of the SHR6390 in combination with anastrozole, pyrotinib, and trastuzumab in patients with ER-positive, HER2-positive breast cancer in the neoadjuvant setting.
- Being tested
- SHR6390, Anastrozole, Pyrotinib, Trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR6390Drug
SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment for 4 cycles
AnastrozoleDrug
Anastrozole 1md, orally once daily for 16 weeks (For premenopausal women, ovarian suppression may be considered)
PyrotinibDrug
Pyrotinib 400mg once daily for 16 weeks
TrastuzumabDrug
Trastuzumab 6mg/kg (loading dose, 8mg/kg), infusion once every 3-week cycle for 5 cycles.
| Study group | Role | What they receive |
|---|---|---|
| SHR6390+Anastrozole+Pyrotinib+Trastuzumab±Ovarian Suppression | Experimental | Not described Receives: Drug: SHR6390; Drug: Anastrozole; Drug: Pyrotinib; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ki67 changes from baseline to 2 weeks after the start of the neoadjuvant therapy
Ki67 changes from baseline to at 2 weeks after the start of the neoadjuvant therapy
Measured: 2 weeks
Secondary outcomes (5)
Ki67 changes from baseline to at surgery
Ki67 changes from baseline to at surgery
Measured: average 19 weeks after the start of the neoadjuvant therapy
Pathological complete response (ypT0/is ypN0) rate
Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ.
Measured: average 19 weeks after the start of the neoadjuvant therapy
Objective response rate (ORR)
ORR includes all patients whose cancer has a partial or complete response according to RECIST 1.1
Measured: average 19 weeks after the start of the neoadjuvant therapy
Invasive disease-free survival (IDFS)
IDFS is defined as the time period between registration and first event (ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, second primary nonbreast invasive cancer)
Measured: 5 years
Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped
Descriptive statistics will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.
Measured: during treatment (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start15 Jan 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (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 Ruijin HospitalThe 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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236310
- Sponsor's protocol ID
- RJBC2001
- Status last verified
- Jan 2020
- First submitted
- 17 Jan 2020
- Last updated
- 22 Jan 2020
- 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 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Neoadjuvant SHR6390 in Combination With Anastrozole, Pyrotinib, and Trastuzumab in Patients With ER-Positive, HER2-Positive Breast Cancer.
- ClinicalTrials.gov ID
- NCT04236310
- Acronym / sponsor ID
- RJBC2001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 15 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Jan 2020 (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.
To evaluate the efficacy and safety of the SHR6390 in combination with anastrozole, pyrotinib, and trastuzumab in patients with ER-positive, HER2-positive breast cancer in the neoadjuvant setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR6390+Anastrozole+Pyrotinib+Trastuzumab±Ovarian Suppression | Experimental | Drug: SHR6390, Drug: Anastrozole, Drug: Pyrotinib, Drug: Trastuzumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures.
- Age at diagnosis ≥18 years and ≤75 years, female.
- Histologically confirmed diagnosis of Unilateral ER+/HER2+ breast cancer. ER-positivity is defined as >1% stained cells；HER2-positivity is defined as IHC 3+ or if IHC scored 2+, in-situ hybridisation (ISH) suggests amplified HER2 gene.
- Tumor diameter >2 centimeters with the clinical stage being classified as from IIa to IIIc.
- ECOG ≤ 1, LVEF ≥ 55%.
Key exclusion criteria (10 listed)
- Evidence of bilateral invasive breast cancer or metastatic disease (M1).
- Pevious treatment with chemotherapy, hormonal therapy, an investigational drug for any type of malignancy, or radiation therapy.
- Any of the following exist in the last 6 months: known or suspected congestive heart failure (≥ NYHA II), persistent arrhythmias (≥ grade 2), atrial fibrillation of any grade, coronary / peripheral bypass, symptomatic congestive heart failure, cerebrovascular accidents (including transient cerebral hemorrhage attacks or symptomatic pulmonary embolism).
- Known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol.
- Active infection or severe symptomatic visceral disease in the last 4 weeks.
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 |
|---|---|---|
| SHR6390SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment for 4 cycles | Drug | SHR6390+Anastrozole+Pyrotinib+Trastuzumab±Ovarian Suppression |
| AnastrozoleAnastrozole 1md, orally once daily for 16 weeks (For premenopausal women, ovarian suppression may be considered) | Drug | SHR6390+Anastrozole+Pyrotinib+Trastuzumab±Ovarian Suppression |
| PyrotinibPyrotinib 400mg once daily for 16 weeks | Drug | SHR6390+Anastrozole+Pyrotinib+Trastuzumab±Ovarian Suppression |
| TrastuzumabTrastuzumab 6mg/kg (loading dose, 8mg/kg), infusion once every 3-week cycle for 5 cycles. | Drug | SHR6390+Anastrozole+Pyrotinib+Trastuzumab±Ovarian Suppression |
Primary outcome
Ki67 changes from baseline to 2 weeks after the start of the neoadjuvant therapy
Time frame: 2 weeks
Ki67 changes from baseline to at 2 weeks after the start of the neoadjuvant therapy
5 secondary outcomes
Ki67 changes from baseline to at surgery
Time frame: average 19 weeks after the start of the neoadjuvant therapy
Pathological complete response (ypT0/is ypN0) rate
Time frame: average 19 weeks after the start of the neoadjuvant therapy
Objective response rate (ORR)
Time frame: average 19 weeks after the start of the neoadjuvant therapy
Invasive disease-free survival (IDFS)
Time frame: 5 years
Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped
Time frame: during treatment (16 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR6390, Anastrozole and Pyrotinib in people with Breast Cancer and HER2-positive Breast Cancer, run by Ruijin 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 6 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: status not confirmed, as of the sponsor's last update on 22 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiayi Wu, Dr. (0086-21-64370045 ext. 602268, pinkscorpio@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ki67 changes from baseline to 2 weeks after the start of the neoadjuvant therapy (time frame: 2 weeks). 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 22 Jan 2020.