Breast CancerPhase 1/2NCT04215003
A Clinical Trial of Breast Cancer Neo-adjuvant Therapy Based on Molecular Pathway in FUSCC
A Phase 1/2 study testing A, B and CL4 in people with Breast Cancer, run by Fudan University at 2 sites in China.
Trial summary
This is a Phase Ib/II, prospective , open-label, single center, Bayesian adaptive design, umbrella study evaluating the efficacy and safety of neo-adjuvant therapy in patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- A, B and CL4
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 20 Jan 2020to 31 Dec 2024
- Phase
- Phase 1/2
- 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
- Age: 18-70 years old Expected survival > 12 months Baseline ECOG Performance Status rating 0-1 Naïve to chemotherapy or hormonal treatments Radiologically confirmed and biopsy diagnosed invasive ductal carcinoma of breast and prepared to be treated surgically Locally advance breast cancer of stage IIb-IIIc No concurrent malignancy (except controlled cervical carcinoma in situ or basal cell carcinoma of skin) Patients have measurable lesions (according to RECIST v1.1 criteria) Intention to cooperate with baseline puncture and neoadjuvant therapy No advanced metastasis or metastasis involving brain or liver Adequate bone marrow function, blood routine examination shows neutrophil count ≥ 1.5x109/L, hemoglobin level ≥ 100 g/L, Platelets ≥ 100 x 109/L Adequate liver and kidney function, serum aminotransferase (AST) ≤ 60U/L, serum total bilirubin ≤ 2.5 times ULN, serum creatinine ≤110μmol/L, urea nitrogen ≤7.1mmol/L No coagulation abnormality Normal heart function, with normal ECG and LVEF ≥ 55% Women of childbearing age agree to take reliable contraceptive measures during clinical trials, and negative serum or urine pregnancy test within 7 days prior to administration No coagulation abnormality Sign the informed consent statement and voluntarily receive follow-ups, treatments, laboratory tests and other research procedures according to protocol.
Who cannot join
- Previous regional or systemic treatment for breast cancer (include but not limited to chemotherapy, radiotherapy, targeted therapy, other clinical trials) Inflammatory breast cancer, bilateral breast cancer or breast cancer already with distant metastasis Complicated with uncontrolled lung disease, severe infection, active peptic ulcer, blood clotting disorders, severe uncontrolled diabetes, connective tissue disorders or bone marrow suppression, and intolerance to neoadjuvant therapy or related treatment Peripheral neuropathy >1 degree caused by any reason History of congestive heart failure, uncontrolled or symptomatic angina, arrhythmias or history of myocardial infarction, refractory hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg); Breast cancer during lactation or pregnancy Unwillingly to receive baseline puncture or neoadjuvant therapy Mental illness or incompliance to treatment caused by other reasons Known history of severe hypersusceptibility to any agents used in the treatment protocol Patients received major surgery or suffered from severe trauma within 2 months of first administration Currently enroll or recently used (30 days within enrollment) other agent under research or involved in other trial Known to be infected with human immunodeficiency virus (HIV) Other circumstances considered to be inappropriate to be enrolled by researchers
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Shao Zhimin
Shanghai, Please Select, 200032
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Zhimin Shao, PhD, zhimingshao@yahoo.com
About this study
Official title: This is a Phase Ib/II, Prospective , Open-label, Single Center, Bayesian Adaptive Design, Umbrella Study Evaluating the Efficacy and Safety of Neo-adjuvant Therapy in Patients With Breast Cancer.
This is a Phase Ib/II, prospective , open-label, single center, Bayesian adaptive design, umbrella study evaluating the efficacy and safety of neo-adjuvant therapy in patients with breast cancer.
- Conditions
- Breast Cancer
- Being tested
- A, B, CL4
- Keywords
- breast cancer, neo-adjuvant therapy, molecular pathway, umbrella trial
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADrug
Paclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle. Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle,6 cycles.
Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle,6 cycles.
BDrug
Paclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle.
CL4Drug
SHR6390（CDK4/6 inhibitor）125 mg qd(three week on one week off); oral letrozole 2.5 mg daily； Adebrelimab was given intravenously, 600mg each time, once every 2 weeks; Premenopause：Goserelin 3.6mg IM IM Q4W.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 6 cycles of Paclitaxel,Carboplatin, Herceptin and Pertuzumab treatment with a good clinical benefit response depending on HR/HER-2 status. Receives: Drug: A |
| B | Experimental | 2 cycles of Paclitaxel,Carboplatin, Herceptin treatment with a good clinical benefit response depending on HR/HER-2 status following surgery Receives: Drug: B |
| CL4 | Experimental | HR+ and HER2-; No correlated pathway variation Receives: Drug: CL4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic Complete Response (pCR)
pCR is defined as the absence of noninvasive tumor residuals in breast and axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy.
Measured: through study completion, up to 24 weeks
Secondary outcomes (1)
Objective Response Rate (ORR)
ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start20 Jan 2020
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215003
- Sponsor's protocol ID
- SCHBCC0N026
- Status last verified
- Jun 2024
- First submitted
- 29 Dec 2019
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen L, Wu WY, Liang F, Liu GY, Yu KD, Wu J, Di GH, Fan L, Wang ZH, Li JJ, Shao ZM. A prospective, phase II, neoadjuvant study based on chemotherapy sensitivity in HR+/HER2- breast cancer-FINEST study. Cancer Commun (Lond). 2025 Apr;45(4):411-421. doi: 10.1002/cac2.12649. Epub 2025 Jan 4.
PubMed 39754712
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This is a Phase Ib/II, Prospective , Open-label, Single Center, Bayesian Adaptive Design, Umbrella Study Evaluating the Efficacy and Safety of Neo-adjuvant Therapy in Patients With Breast Cancer.
- ClinicalTrials.gov ID
- NCT04215003
- Acronym / sponsor ID
- SCHBCC0N026
- Conditions
- Breast Cancer
- Keywords
- breast cancer, neo-adjuvant therapy, molecular pathway, umbrella trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 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.
This is a Phase Ib/II, prospective , open-label, single center, Bayesian adaptive design, umbrella study evaluating the efficacy and safety of neo-adjuvant therapy in patients with breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: A6 cycles of Paclitaxel,Carboplatin, Herceptin and Pertuzumab treatment with a good clinical benefit response depending on HR/HER-2 status. |
| B | Experimental | Drug: B2 cycles of Paclitaxel,Carboplatin, Herceptin treatment with a good clinical benefit response depending on HR/HER-2 status following surgery |
| CL4 | Experimental | Drug: CL4HR+ and HER2-; No correlated pathway variation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age: 18-70 years old Expected survival > 12 months Baseline ECOG Performance Status rating 0-1 Naïve to chemotherapy or hormonal treatments Radiologically confirmed and biopsy diagnosed invasive ductal carcinoma of breast and prepared to be treated surgically Locally advance breast cancer of stage IIb-IIIc No concurrent malignancy (except controlled cervical carcinoma in situ or basal cell carcinoma of skin) Patients have measurable lesions (according to RECIST v1.1 criteria) Intention to cooperate with baseline puncture and neoadjuvant therapy No advanced metastasis or metastasis involving brain or liver Adequate bone marrow function, blood routine examination shows neutrophil count ≥ 1.5x109/L, hemoglobin level ≥ 100 g/L, Platelets ≥ 100 x 109/L Adequate liver and kidney function, serum aminotransferase (AST) ≤ 60U/L, serum total bilirubin ≤ 2.5 times ULN, serum creatinine ≤110μmol/L, urea nitrogen ≤7.1mmol/L No coagulation abnormality Normal heart function, with normal ECG and LVEF ≥ 55% Women of childbearing age agree to take reliable contraceptive measures during clinical trials, and negative serum or urine pregnancy test within 7 days prior to administration No coagulation abnormality Sign the informed consent statement and voluntarily receive follow-ups, treatments, laboratory tests and other research procedures according to protocol.
Key exclusion criteria (1 listed)
- Previous regional or systemic treatment for breast cancer (include but not limited to chemotherapy, radiotherapy, targeted therapy, other clinical trials) Inflammatory breast cancer, bilateral breast cancer or breast cancer already with distant metastasis Complicated with uncontrolled lung disease, severe infection, active peptic ulcer, blood clotting disorders, severe uncontrolled diabetes, connective tissue disorders or bone marrow suppression, and intolerance to neoadjuvant therapy or related treatment Peripheral neuropathy >1 degree caused by any reason History of congestive heart failure, uncontrolled or symptomatic angina, arrhythmias or history of myocardial infarction, refractory hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg); Breast cancer during lactation or pregnancy Unwillingly to receive baseline puncture or neoadjuvant therapy Mental illness or incompliance to treatment caused by other reasons Known history of severe hypersusceptibility to any agents used in the treatment protocol Patients received major surgery or suffered from severe trauma within 2 months of first administration Currently enroll or recently used (30 days within enrollment) other agent under research or involved in other trial Known to be infected with human immunodeficiency virus (HIV) Other circumstances considered to be inappropriate to be enrolled by researchers
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 |
|---|---|---|
| APaclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle. Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle,6 cycles. Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle,6 cycles. | Drug | A |
| BPaclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle. | Drug | B |
| CL4SHR6390（CDK4/6 inhibitor）125 mg qd(three week on one week off); oral letrozole 2.5 mg daily； Adebrelimab was given intravenously, 600mg each time, once every 2 weeks; Premenopause：Goserelin 3.6mg IM IM Q4W. | Drug | CL4 |
Primary outcome
pathologic Complete Response (pCR)
Time frame: through study completion, up to 24 weeks
pCR is defined as the absence of noninvasive tumor residuals in breast and axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy.
1 secondary outcome
Objective Response Rate (ORR)
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Derived from this study: PubMed 39754712Chen L, Wu WY, Liang F, Liu GY, Yu KD, Wu J, Di GH, Fan L, Wang ZH, Li JJ, Shao ZM. A prospective, phase II, neoadjuvant study based on chemotherapy sensitivity in HR+/HER2- breast cancer-FINEST study. Cancer Commun (Lond). 2025 Apr;45(4):411-421. doi: 10.1002/cac2.12649. Epub 2025 Jan 4.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing A, B and CL4 in people with Breast Cancer, run by Fudan University at 2 sites 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 1 inclusion and 1 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 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
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 Zhimin Shao, MD.PhD. (18017312288, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic Complete Response (pCR) (time frame: through study completion, up to 24 weeks). 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 NCT04215003, 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 6 Jun 2024.