Breast CancerPhase 1NCT05251766
Nab-paclitaxel Compared With Docetaxel in the Neoadjuvant Chemotherapy Breast Cancer
A Phase 1 study testing Nab paclitaxel and Docetaxel in people with Breast Cancer and Chemotherapy Effect, run by Xuli Meng.
Trial summary
Comparison of docetaxel and Nab-paclitaxel in neoadjuvant chemotherapy for breast cancer Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy Effect
- What is being tested?
- Nab paclitaxel and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2022to 30 Jun 2023
- Phase
- Phase 1
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with age range ≥ 18 years;
- a single invasive breast cancer conforming to the clinical diagnostic criteria and histologically confirmed.
- HER2 negative breast cancer, tumor >2 cm, clinical staging conforms to T2-4 phase (defined by immunohistochemistry as 0-1+ or by immunohistochemistry as 2+, without HER2 amplification by Fluorescence in situ hybridization(FISH), chemiluminescent in situ hybridization(CISH) or other amplification tests).
- Known hormone receptor status (estrogen receptor [ER], progesterone receptor [PR]), known Ki67 value;
- Eastern Cooperative Oncology Group(ECOG) performance status is 0 or 1;
- patients have not previously had breast cancer treatment.
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- During the study, be able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits;
- Subjects have the ability to understand, agree and sign the study informed consent form (ICF) before initiating any protocol related procedures; The subject has the ability to express consent (when applicable);
- Normal blood, kidney and liver functions (ANC ≥ 1500 / mm3, platelet（PLT）≥ 100000 / mm3, serum creatinine and total bilirubin ≤ 1.5 times of the upper limit of normal, glutamic oxalacetic transaminase(AST) and glutamic-pyruvic transaminase（ALT） ≤ 3 times of the upper limit of normal).
Who cannot join
- bilateral invasive breast cancer, metastatic disease or other malignant tumors.
- Surgical axillary staging surgery was performed within 6 months before entering the study;
- Pregnant or lactating women; Patients with fertility are unwilling or unable to take effective contraceptive measures;
- before the start of the study, radiotherapy, chemotherapy, biological therapy and / or hormone therapy for the current diagnosis of breast cancer were carried out.
- Patients with central nervous system metastasis or > grade 1 peripheral neuropathy;
- Patients with severe myelosuppression at the time of screening;
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- Patients with severe liver dysfunction (child's class III) or renal dysfunction at the time of screening;
- Other concomitant diseases that the researchers believe are seriously harmful to the safety of patients or will hinder the implementation or completion of treatment plan (such as untreated congenital heart disease, glomerulonephritis, etc.);
- Allergic to albumin for injection, paclitaxel, epirubicin, cyclophosphamide and docetaxel;
- Patients with mental disorders;
- Subjects who are participating in other clinical studies or whose first medication time is less than 4 weeks (or 5 half lives of the study drug) from the end of the previous clinical study (last administration);
- Other situations that may affect the progress of clinical research and the judgment of research results and are not suitable for inclusion in the study.
About this study
Official title: Nab-paclitaxel Compared With Docetaxel Combined With Epirubicin and Cyclophosphamide in the Neoadjuvant Chemotherapy Breast Cancer
Comparison of docetaxel and Nab-paclitaxel in neoadjuvant chemotherapy for breast cancer
Read the detailed description
- To analyze and compare the efficacy and safety of epirubicin + cyclophosphamide (EC) followed by docetaxel and EC followed by nab-paclitaxel in neoadjuvant chemotherapy of breast cancer; 2. To analyze and compare the efficacy and safety of nab-paclitaxel combined with epirubicin + cyclophosphamide (EC) chemotherapy regimen in neoadjuvant therapy of breast cancer, so as to provide a new treatment option for patients with human epidermal growth factor receptor 2(HER2)-negative breast cancer.
- Conditions
- Breast Cancer, Chemotherapy Effect
- Being tested
- Nab paclitaxel, Docetaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab paclitaxelDrug
Also called Aiyue(Jiangsu Hengrui Pharmaceuticals Co.)
To analyze and compare the efficacy and safety of epirubicin + cyclophosphamide (EC) followed by docetaxel and EC followed by nab-paclitaxel in neoadjuvant chemotherapy of breast cancer; To analyze and compare the efficacy and safety of nab-paclitaxel combined with epirubicin + cyclophosphamide (EC) chemotherapy regimen in neoadjuvant therapy of breast cancer, so as to provide a new treatment option for patients with HER2-negative breast cancer.
DocetaxelDrug
Also called Tianlun(Yangzijiang Pharmaceuticals Co.)
To analyze and compare the efficacy and safety of epirubicin + cyclophosphamide (EC) followed by docetaxel and EC followed by nab-paclitaxel in neoadjuvant chemotherapy of breast cancer; To analyze and compare the efficacy and safety of nab-paclitaxel combined with epirubicin + cyclophosphamide (EC) chemotherapy regimen in neoadjuvant therapy of breast cancer, so as to provide a new treatment option for patients with HER2-negative breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| Arm1: epirubicin + cyclophosphamide followed by docetaxel | Active comparator | Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 4 cycles, Follow Docetaxel :75 mg/m2, D1, q3W, 4 cycles Receives: Drug: Docetaxel |
| Arm2: epirubicin + cyclophosphamide followed by nab-paclitaxel | Experimental | Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 4 cycles, Follow Nab-paclitaxel :260 mg/m2, d1, q3W; 4 cycles Receives: Drug: Nab paclitaxel |
| Arm3: nab-paclitaxel combined with epirubicin + cyclophosphamide | Experimental | Nab-paclitaxel :260 mg/m2, D1, q3W; Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 6 cycles Receives: Drug: Nab paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response (pCR) rate
Proportion of PCR patients in enrolled breast cancer patients
Measured: 21 weeks
Secondary outcomes (1)
Total clinical response rate
The clinical response rate was assessed by ultrasound measurement of tumor size
Measured: 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start20 Apr 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jun 2023 (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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuli Meng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuli Meng, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251766
- Sponsor's protocol ID
- SRMBCNabP2022
- Status last verified
- Feb 2022
- First submitted
- 18 Jan 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nab-paclitaxel Compared With Docetaxel Combined With Epirubicin and Cyclophosphamide in the Neoadjuvant Chemotherapy Breast Cancer
- ClinicalTrials.gov ID
- NCT05251766
- Acronym / sponsor ID
- SRMBCNabP2022
- Conditions
- Breast Cancer, Chemotherapy Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xuli MengUniversity, hospital or other
- Study start
- 20 Apr 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 23 Feb 2022 (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.
Comparison of docetaxel and Nab-paclitaxel in neoadjuvant chemotherapy for breast cancer
Detailed description
- To analyze and compare the efficacy and safety of epirubicin + cyclophosphamide (EC) followed by docetaxel and EC followed by nab-paclitaxel in neoadjuvant chemotherapy of breast cancer; 2. To analyze and compare the efficacy and safety of nab-paclitaxel combined with epirubicin + cyclophosphamide (EC) chemotherapy regimen in neoadjuvant therapy of breast cancer, so as to provide a new treatment option for patients with human epidermal growth factor receptor 2(HER2)-negative breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm1: epirubicin + cyclophosphamide followed by docetaxel | Active comparator | Drug: DocetaxelEpirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 4 cycles, Follow Docetaxel :75 mg/m2, D1, q3W, 4 cycles |
| Arm2: epirubicin + cyclophosphamide followed by nab-paclitaxel | Experimental | Drug: Nab paclitaxelEpirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 4 cycles, Follow Nab-paclitaxel :260 mg/m2, d1, q3W; 4 cycles |
| Arm3: nab-paclitaxel combined with epirubicin + cyclophosphamide | Experimental | Drug: Nab paclitaxelNab-paclitaxel :260 mg/m2, D1, q3W; Epirubicin :90 mg/m2, D1, q3W; Cyclophosphamide :600 mg/m2, D1, q3W; 6 cycles |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female patients with age range ≥ 18 years;
- a single invasive breast cancer conforming to the clinical diagnostic criteria and histologically confirmed.
- HER2 negative breast cancer, tumor >2 cm, clinical staging conforms to T2-4 phase (defined by immunohistochemistry as 0-1+ or by immunohistochemistry as 2+, without HER2 amplification by Fluorescence in situ hybridization(FISH), chemiluminescent in situ hybridization(CISH) or other amplification tests).
- Known hormone receptor status (estrogen receptor [ER], progesterone receptor [PR]), known Ki67 value;
- Eastern Cooperative Oncology Group(ECOG) performance status is 0 or 1;
Key exclusion criteria (12 listed)
- bilateral invasive breast cancer, metastatic disease or other malignant tumors.
- Surgical axillary staging surgery was performed within 6 months before entering the study;
- Pregnant or lactating women; Patients with fertility are unwilling or unable to take effective contraceptive measures;
- before the start of the study, radiotherapy, chemotherapy, biological therapy and / or hormone therapy for the current diagnosis of breast cancer were carried out.
- Patients with central nervous system metastasis or > grade 1 peripheral neuropathy;
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 |
|---|---|---|
| Nab paclitaxelAlso: Aiyue(Jiangsu Hengrui Pharmaceuticals Co.)To analyze and compare the efficacy and safety of epirubicin + cyclophosphamide (EC) followed by docetaxel and EC followed by nab-paclitaxel in neoadjuvant chemotherapy of breast cancer; To analyze and compare the efficacy and safety of nab-paclitaxel combined with epirubicin + cyclophosphamide (EC) chemotherapy regimen in neoadjuvant therapy of breast cancer, so as to provide a new treatment option for patients with HER2-negative breast cancer. | Drug | Arm2: epirubicin + cyclophosphamide followed by nab-paclitaxel, Arm3: nab-paclitaxel combined with epirubicin + cyclophosphamide |
| DocetaxelAlso: Tianlun(Yangzijiang Pharmaceuticals Co.)To analyze and compare the efficacy and safety of epirubicin + cyclophosphamide (EC) followed by docetaxel and EC followed by nab-paclitaxel in neoadjuvant chemotherapy of breast cancer; To analyze and compare the efficacy and safety of nab-paclitaxel combined with epirubicin + cyclophosphamide (EC) chemotherapy regimen in neoadjuvant therapy of breast cancer, so as to provide a new treatment option for patients with HER2-negative breast cancer. | Drug | Arm1: epirubicin + cyclophosphamide followed by docetaxel |
Primary outcome
pathologic complete response (pCR) rate
Time frame: 21 weeks
Proportion of PCR patients in enrolled breast cancer patients
1 secondary outcome
Total clinical response rate
Time frame: 21 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nab paclitaxel and Docetaxel in people with Breast Cancer and Chemotherapy Effect, run by Xuli Meng.
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 12 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 23 Feb 2022. 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 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?
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?
pathologic complete response (pCR) rate (time frame: 21 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 23 Feb 2022.