Breast CancerNCT05636644
Neoadjuvant Effect of Albumin Binding Paclitaxel Compared With Common Paclitaxel in Breast Cancer：an Observational Single Center Study of Clinical Efficacy in Adjuvant Chemotherapy
An observational study of Breast Cancer, run by Mei Zhang at 1 site in China.
Trial summary
In recent years, the incidence rate of breast cancer has remained high. In China, breast cancer is the malignant tumor with the highest incidence rate among women. Although the research and development of various targeted drugs and the improvement of clinical treatment system have effectively improved the 5-year… Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Taxol
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2022to 16 Jun 2025
- Phase
- Observational
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients with TNM stage T2-4N0-3M0 who were hospitalized in the breast surgery department of Shandong Qianfoshan Hospital from the time when the ethical approval document was obtained to December 2024.
Who may be able to join
- 1. Female breast cancer patients aged ≥ 20 years and ≤ 70 years, with informed consent and meeting the treatment standard of neoadjuvant chemotherapy scheme; 2. Invasive breast cancer with TNM stageT2-4N0-3M0; 3.No treatment for breast cancer before enrollment, such as chemotherapy, targeted therapy and endocrine therapy; 4.All patients underwent thick needle biopsy of breast tumors (patients suspected of axillary lymph node metastasis should undergo lymph node biopsy) to determine the status of ER, PR, HER-2 and Ki-67; 5. All patients had normal cardiopulmonary function, liver and kidney function.
Who cannot join
- 1. The patient does not cooperate and is unwilling to sign the informed consent form; 2. The tumor has been confirmed to have distant metastasis; 3. Antitumor therapy, hormone replacement therapy and other breast cancer related treatments were performed before enrollment; 4. Any other malignant tumor is combined; 5. Patients with active infection, HIV history or chronic hepatitis B or C; 6. Persons with abnormal heart and lung functions or liver and kidney functions; 7.Other clinical researchers in recent 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)
Jinan, Shandong
Mei Zhang, doctor, 13589102156, zhangmei@sdhospital.com.cn
Guoming Liu, master
About this study
In recent years, the incidence rate of breast cancer has remained high. In China, breast cancer is the malignant tumor with the highest incidence rate among women. Although the research and development of various targeted drugs and the improvement of clinical treatment system have effectively improved the 5-year survival rate of breast cancer patients in China, the clinical treatment effect of breast cancer is still unsatisfactory. It is speculated that the main reasons for the poor clinical efficacy of breast cancer are drug tolerance, recurrence, distant metastasis, etc., which further leads to some limitations in the exploration of clinical drug development and regulatory mechanism. Paclitaxels are common chemotherapeutic drugs, which have been widely used in the treatment of breast cancer, ovarian cancer and some lung cancer. In2005, albumin binding paclitaxel was approved by FDA for the treatment of breast cancer patients. It is highly hydrophobic and requires a mixture of polyethylene castor oil and ethanol. These solvents will increase the toxic reactions of patients treated with paclitaxel, including severe allergic and anaphylactic reactions, and irreversible peripheral neuropathy, usually requiring the use of corticosteroids and antihistamines in advance.In order to further confirm the advantages of albumin binding paclitaxel and common paclitaxel chemotherapeutic drugs in neoadjuvant chemotherapy of breast cancer, this project intends to explore albumin binding based on different molecular types of breast cancer (luminal a, B, HER2 +, triple negative) An observational study on the efficacy of neoadjuvant chemotherapy with a-paclitaxel and common paclitaxel chemotherapeutic drugs. Randomized grouping confirmed the effectiveness of albumin binding paclitaxel replacing common paclitaxel in neoadjuvant chemotherapy of breast cancer with different molecular types, providing evidence-based medical evidence for the selection of paclitaxel chemotherapeutic drugs based on breast cancer molecular types. At the same time, the patients with poor efficacy among the patients who selected the neoadjuvant chemotherapy scheme for breast cancer according to the guidelines of NCCN and CSCO were screened for clinical transformation research (including basic experimental research, follow-up intensive treatment selection, and providing basis for entering other drug clinical trials). For the patients who achieved the clinical efficacy of PCR with neoadjuvant chemotherapy, we further analyzed the reasons to explore a better scheme of neoadjuvant chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- Taxol
- Keywords
- Paclitaxel，Neoadjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaxolDrug
All patients received TAC regimen: both groups received AC (epirubicin 75 mg/m ² and cyclophosphamide 500mg/m ²)， Group A was treated with docetaxel for 6 cycles every 3 weeks (75 mg/m on the first day ²)； Group B received six cycles of nab paclitaxel (125 mg/m ²)， every 3 weeks is a course of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group A | anthracyclines+cyclophosphamide+other paclitaxel drugs | |
| Group B | anthracyclines+cyclophosphamide+nab paclitaxel Receives: Drug: Taxol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete remission (pCR)
Grade I: tumor focus basically unchanged; Grade II: ≤ 30% tumor cells disappear; Grade III: about 30-90% of tumor tissues disappear; Grade IV: ≥ 90% of tumor cells disappeared; Grade V: no residual invasive cancer tissue. Among them, if there is grade III or above, it indicates that the treatment is effective; if there is grade II or below, it indicates that the treatment is invalid; and grade V 5 indicates that the patient has reached pCR.
Measured: June 2025
Secondary outcomes (2)
Disease free survival (DFS)
Measured: June 2025
Complete remission (CR), partial remission (PR) and objective remission rate (ORR) of solid tumors
① Complete remission (CR): all cancer foci disappeared, no new tumor foci appeared and maintained for at least 4 weeks; ② Partial remission (PR): the sum of the maximum diameters of tumor lesions decreased by ≥ 30% for at least 4 weeks; ③ Disease stability (SD): the sum of the largest diameters of tumor lesions decreased to PR, or increased to PD; ④ Disease progression (PD): The sum of the maximum diameters of tumor lesions increases by at least 20%, and its absolute value increases by at least 5 mm. The appearance of new lesions is also called PD. If the tumor has CR and PR, the original scheme is proved to be effective, and continue to treat according to the original scheme; In case of PD and SD, replace the scheme.
Measured: June 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start4 Nov 2022
- Primary completion1 Feb 2025 (estimated)
- Study completion16 Jun 2025 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mei Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mei Zhang, Qianfoshan Hospital
- Investigators
- Guoming Liu, master, Principal investigator, The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)Yonghao Li, master, Principal investigator, The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)Xinlei Zhang, master, Principal investigator, The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)Ximei Sun, master, Principal investigator, The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636644
- Sponsor's protocol ID
- YXH2022ZX02167
- Status last verified
- Nov 2022
- First submitted
- 24 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Effect of Albumin Binding Paclitaxel Compared With Common Paclitaxel in Breast Cancer：an Observational Single Center Study of Clinical Efficacy in Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT05636644
- Acronym / sponsor ID
- YXH2022ZX02167
- Conditions
- Breast Cancer
- Keywords
- Paclitaxel，Neoadjuvant chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Mei ZhangUniversity, hospital or other
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 16 Jun 2025 (estimated)
- First posted
- 5 Dec 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.
In recent years, the incidence rate of breast cancer has remained high. In China, breast cancer is the malignant tumor with the highest incidence rate among women. Although the research and development of various targeted drugs and the improvement of clinical treatment system have effectively improved the 5-year survival rate of breast cancer patients in China, the clinical treatment effect of breast cancer is still unsatisfactory. It is speculated that the main reasons for the poor clinical efficacy of breast cancer are drug tolerance, recurrence, distant metastasis, etc., which further leads to some limitations in the exploration of clinical drug development and regulatory mechanism. Paclitaxels are common chemotherapeutic drugs, which have been widely used in the treatment of breast cancer, ovarian cancer and some lung cancer. In2005, albumin binding paclitaxel was approved by FDA for the treatment of breast cancer patients. It is highly hydrophobic and requires a mixture of polyethylene castor oil and ethanol. These solvents will increase the toxic reactions of patients treated with paclitaxel, including severe allergic and anaphylactic reactions, and irreversible peripheral neuropathy, usually requiring the use of corticosteroids and antihistamines in advance.In order to further confirm the advantages of albumin binding paclitaxel and common paclitaxel chemotherapeutic drugs in neoadjuvant chemotherapy of breast cancer, this project intends to explore albumin binding based on different molecular types of breast cancer (luminal a, B, HER2 +, triple negative) An observational study on the efficacy of neoadjuvant chemotherapy with a-paclitaxel and common paclitaxel chemotherapeutic drugs. Randomized grouping confirmed the effectiveness of albumin binding paclitaxel replacing common paclitaxel in neoadjuvant chemotherapy of breast cancer with different molecular types, providing evidence-based medical evidence for the selection of paclitaxel chemotherapeutic drugs based on breast cancer molecular types. At the same time, the patients with poor efficacy among the patients who selected the neoadjuvant chemotherapy scheme for breast cancer according to the guidelines of NCCN and CSCO were screened for clinical transformation research (including basic experimental research, follow-up intensive treatment selection, and providing basis for entering other drug clinical trials). For the patients who achieved the clinical efficacy of PCR with neoadjuvant chemotherapy, we further analyzed the reasons to explore a better scheme of neoadjuvant chemotherapy.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –anthracyclines+cyclophosphamide+other paclitaxel drugs |
| Group B | – | Drug: Taxolanthracyclines+cyclophosphamide+nab paclitaxel |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients with TNM stage T2-4N0-3M0 who were hospitalized in the breast surgery department of Shandong Qianfoshan Hospital from the time when the ethical approval document was obtained to December 2024.
Key inclusion criteria (1 listed)
- 1. Female breast cancer patients aged ≥ 20 years and ≤ 70 years, with informed consent and meeting the treatment standard of neoadjuvant chemotherapy scheme; 2. Invasive breast cancer with TNM stageT2-4N0-3M0; 3.No treatment for breast cancer before enrollment, such as chemotherapy, targeted therapy and endocrine therapy; 4.All patients underwent thick needle biopsy of breast tumors (patients suspected of axillary lymph node metastasis should undergo lymph node biopsy) to determine the status of ER, PR, HER-2 and Ki-67; 5. All patients had normal cardiopulmonary function, liver and kidney function.
Key exclusion criteria (1 listed)
- 1. The patient does not cooperate and is unwilling to sign the informed consent form; 2. The tumor has been confirmed to have distant metastasis; 3. Antitumor therapy, hormone replacement therapy and other breast cancer related treatments were performed before enrollment; 4. Any other malignant tumor is combined; 5. Patients with active infection, HIV history or chronic hepatitis B or C; 6. Persons with abnormal heart and lung functions or liver and kidney functions; 7.Other clinical researchers in recent 3 months.
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 |
|---|---|---|
| TaxolAll patients received TAC regimen: both groups received AC (epirubicin 75 mg/m ² and cyclophosphamide 500mg/m ²)， Group A was treated with docetaxel for 6 cycles every 3 weeks (75 mg/m on the first day ²)； Group B received six cycles of nab paclitaxel (125 mg/m ²)， every 3 weeks is a course of treatment. | Drug | Group B |
Primary outcome
Pathological complete remission (pCR)
Time frame: June 2025
Grade I: tumor focus basically unchanged; Grade II: ≤ 30% tumor cells disappear; Grade III: about 30-90% of tumor tissues disappear; Grade IV: ≥ 90% of tumor cells disappeared; Grade V: no residual invasive cancer tissue. Among them, if there is grade III or above, it indicates that the treatment is effective; if there is grade II or below, it indicates that the treatment is invalid; and grade V 5 indicates that the patient has reached pCR.
2 secondary outcomes
Disease free survival (DFS)
Time frame: June 2025
Complete remission (CR), partial remission (PR) and objective remission rate (ORR) of solid tumors
Time frame: June 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- 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.
Guoming Liu, master principal investigator
The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)
Yonghao Li, master principal investigator
The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)
Xinlei Zhang, master principal investigator
The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Mei Zhang 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 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 5 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.
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 Mei Zhang, doctor (13589102156, zhangmei@sdhospital.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete remission (pCR) (time frame: June 2025). 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 5 Dec 2022.