Breast CancerPhase 4NCT05420467
A Study for the Adjuvant Treatment of Breast Cancer
A Phase 4 study testing Docetaxel, Carboplatin and Trastuzumab in people with Breast Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Studies on postoperative adjuvant albumin paclitaxel in domestic breast cancer patients are less reported, especially in large samples, and more studies focus more on the safety and tolerability of albumin paclitaxel use. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Docetaxel, Carboplatin and Trastuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,413 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2022to 20 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥18 years;
- Histopathologically or cytologically confirmed breast cancer patients with the following characteristics:1. stage I to III breast cancer; 2. operable primary lesion with no evidence of distant metastasis (M0);
- known hormone receptor status (estrogen receptor [ER], progesterone receptor [PR]) and HER2 status with known Ki67 expression levels; (ER/PR positive defined as stained cells >1%, HER2 positive defined as IHC 3+ or IHC 2+ with a positive FISH test);
- Triple-negative breast cancer (TNBC): ER/PR negative, HER2 negative; tumor >2cm or lymph node metastasis with clear postoperative pathological evidence; Luminal breast cancer: ER>1%, HER2 negative, postoperative pathological evidence definite lymph node metastasis (different adjuvant chemotherapy regimens depending on whether the lymph nodes are N1 or N2-3); HER2-positive breast cancer: HER2-positive, regardless of ER/PR status; (the above classification determines enrollment and adjuvant therapy, and does not represent the corresponding molecular typing definition);
- Patients who have undergone breast cancer resection and systemic intrathoracic lymph node dissection; surgical resection is R0 resection; patients who need postoperative adjuvant chemotherapy as judged by the investigator;
- Start of adjuvant therapy within 21 days of the time of surgery is appropriate ;
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- ECOG physical fitness score of 0-1 with an expected survival of >6 months ;
- Patients have not been treated with a paclitaxel regimen prior to enrolment ;
- Adjuvant chemotherapy should not be performed concurrently with endocrine therapy drugs such as tamoxifen/aromatase inhibitors or postoperative radiotherapy;
- Women of childbearing age must have taken reliable contraceptive measures, or performed a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and be willing to use appropriate contraceptives during the trial and 8 weeks after the last dose of the trial drug;
- Electrocardiogram (ECG) and echocardiography must confirm normal cardiac function within 3 months prior to randomization. Left ventricular ejection fraction (LVEF) must be ≥55% for patients receiving anthracycline-containing chemotherapy regimens and targeted therapy ;
- Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal; AST and ALT ≤3 times the upper limit of normal; total bilirubin ≤1.5 times the upper limit of normal, or ≤2.5 times the upper limit of normal when the patient has Gilbert's syndrome ;
- Bone marrow function: neutrophils≥1.5×109/L, platelets≥100×109/L, hemoglobin≥90g/L;
- Able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits during the study period;
- Subjects have the ability to understand, agree and sign the Informed Consent Form (ICF) for the study prior to initiating any protocol-related procedures; subjects have the ability to express consent (if applicable).
Who cannot join
- Advanced and/or inoperable patients with distant metastasis confirmed by imaging evidence or pathology;
- Other malignant tumors have occurred in the past 5 years, except for skin cancers of cured cervical carcinoma in situ and non-melanoma;
- Pregnant or breastfeeding women; patients with childbearing potential who are unwilling or unable to take effective contraceptive measures;
- The molecular status of ER/PR and HER2 and Ki67 cannot be determined;
- Patients with CNS metastases or > grade 1 peripheral neuropathy;
- Severe cardiovascular disease: Grade II or higher myocardial ischaemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥ 470 ms); Grade III-IV cardiac insufficiency according to NYHA criteria, or cardiac ultrasound indicating a left ventricular ejection fraction (LVEF) of <50%;
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- Patients with hypertension that cannot be reduced to the normal range after antihypertensive medication (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg);
- Received major surgical operations or suffered severe traumatic injury, fracture or ulcer within 4 weeks of enrollment;
- Patients with severe myelosuppression at screening;
- Patients with severe liver dysfunction (Child's Class III) or renal dysfunction at screening ;
- Arterial/venous thrombotic events such as cardiovascular and cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction, myocardial infarction), deep vein thrombosis and pulmonary embolism, that occurred within 6 months before randomization;
- Patients with hypersensitivity to any of the components of albumin paclitaxel, epirubicin, cyclophosphamide, docetaxel, trastuzumab, and pertuzumab;
- Patients with psychiatric disorders;
- Subjects who are participating in another clinical study or whose first dose was administered less than 4 weeks (or 5 half-lives of the study drug) from the end of the previous clinical study (last dose) ;
- The investigator judges other situations that may affect the clinical research and the judgment of the research results and are not suitable for inclusion in the research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Yiding Chen, 571-87784527, ydchen@zju.edu.cn
About this study
Official title: A Prospective, Open-label, Non-inferiority Study to Evaluate Injectable Albumin-bound Paclitaxel Versus Docetaxel for the Adjuvant Treatment of Breast Cancer
Studies on postoperative adjuvant albumin paclitaxel in domestic breast cancer patients are less reported, especially in large samples, and more studies focus more on the safety and tolerability of albumin paclitaxel use. Head-to-head studies of white violet and docetaxel are not supported by data at this time, but some studies have shown that docetaxel-induced long-term Other adverse effects such as myelosuppression, hepatotoxicity and hypersensitivity reactions can have a serious impact on quality of life. Therefore, this study aims to analyse the efficacy and safety of albumin paclitaxel and docetaxel in the adjuvant treatment of breast cancer in a large randomized controlled trial, and to further analyse the efficacy and safety of albumin paclitaxel in combination with chemotherapy for postoperative breast cancer in different subtypes of breast cancer patients, in order to obtain more realistic data and provide new treatment options for breast cancer patients.
Read the detailed description
At present, the treatment of early-stage breast cancer is mainly surgical, supplemented by chemotherapy, endocrine therapy, radiotherapy, targeted therapy and other comprehensive treatment methods, through the use of a variety of comprehensive and individualized treatment plans led to a significant improvement in the quality of life and survival of breast cancer patients. Systematic adjuvant therapy after surgery is also gaining increasing attention, with a large number of randomized clinical trials worldwide . The effectiveness of adjuvant therapy in reducing the recurrence of breast cancer and improving survival has been demonstrated in a number of randomized clinical trials worldwide. Adjuvant therapy after surgery is recommended in NCCN guidelines, ESMO, St. Gallen and other guidelines or expert consensus.
The use of albumin paclitaxel in the postoperative adjuvant treatment of breast cancer has been reported overseas, and a phase II clinical study published in 2017 investigated the tolerability and feasibility of dose dense doxorubicin combined with cyclophosphamide followed by nab-paclitaxel (AC-nP) chemotherapy in patients with high-risk early-stage breast cancer in adjuvant treatment. The results suggested that this regimen was well tolerated, with an incidence of granular deficiency with fever 5 of 2%, suggesting the safety of weekly treatment with nab-paclitaxel.
Another study evaluated the safety of dose-dense AC-nP regimens in women with high-risk breast cancer. Enrolled patients received 4 cycles of AC (every 2 weeks) followed by nab-P (every 2 weeks). The most common eventual adverse reaction was peripheral neuropathy, although approximately 80% of patients were grade 1-2, and the patient's neuropathy gradually improved after the end of treatment. This suggests that in early breast cancer, the use of dose-dense AC followed by nab-P is feasible with predictable AEs .
In summary, studies on postoperative adjuvant albumin paclitaxel in domestic breast cancer patients are less reported, especially in large samples, and more studies focus more on the safety and tolerability of albumin paclitaxel use. Head-to-head studies of white violet and docetaxel are not supported by data at this time, but some studies have shown that docetaxel-induced long-term Other adverse effects such as myelosuppression, hepatotoxicity and hypersensitivity reactions can have a serious impact on quality of life. Therefore, this study aim to conduct a prospective, randomized, open-label, multi-center clinical study to analyse the efficacy and safety of albumin paclitaxel and docetaxel in the adjuvant treatment of breast cancer in a large randomized controlled trial, and to further analyse the efficacy and safety of albumin paclitaxel in combination with chemotherapy for postoperative breast cancer in different subtypes of breast cancer patients, in order to obtain more realistic data and provide new treatment options for breast cancer patients.
- Conditions
- Breast Cancer
- Being tested
- Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Nab paclitaxel
- Keywords
- breast cancer, adjuvant therapy, Docetaxel, albumin paclitaxel, TCbHP, nPCbHP, ddEC-wnP, TC, nPC, EC-T
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
75 mg/m2, d1, q3w,6 cycles
CarboplatinDrug
AUC 6, d1, q3w,6 cycles
TrastuzumabDrug
starting dose 8 mg/kg, maintenance dose 6 mg/kg, d1, q3w,6 cycles
PertuzumabDrug
starting dose of 840 mg, maintenance dose of 420 mg, d1, q3w ,6 cycles
Nab paclitaxelDrug
220 mg/m2, d1, q3w,6 cycles
EpirubicinDrug
90 mg/m2, d1, q3w ,4 cycles ,followed by docetaxel
CyclophosphamideDrug
600 mg/m2, d1, q3w × 4 cycles followed by docetaxel
DocetaxelDrug
100 mg/m2, d1, q3w × 4 cycles
EpirubicinDrug
90 mg/m2,d1, q2w × 4 cycles followed by nab-paclitaxel
CyclophosphamideDrug
600 mg/m2, d1, q2w × 4 cycles followed by nab-paclitaxel
Nab paclitaxelDrug
125 mg/m2, d1,8,15, q3w× 4 cycles
CyclophosphamideDrug
600 mg/m2, d1, q3w × 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| TCbHP | Active comparator | HER2-positive breast cancer Receives: Drug: Docetaxel; Drug: Carboplatin; Drug: Trastuzumab; Drug: Pertuzumab |
| nPCbHP | Experimental | HER2-positive breast cancer Receives: Drug: Carboplatin; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Nab paclitaxel |
| EC-T | Active comparator | Luminal breast cancer (HER2-, more than 4 lymph node metastases), and triple negative breast cancer Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel |
| ddEC-wnP | Experimental | Luminal breast cancer (HER2-, more than 4 lymph node metastases), and triple negative breast cancer Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Nab paclitaxel |
| TC | Active comparator | Luminal breast cancer (HER2-, with 1-3 lymph nodes) Receives: Drug: Docetaxel; Drug: Cyclophosphamide |
| nPC | Experimental | Luminal breast cancer (HER2-, with 1-3 lymph nodes) Receives: Drug: Nab paclitaxel; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year DFS
5-year disease-free survival
Measured: 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start10 Jul 2022 (estimated)
- Primary completion10 Jul 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,413 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420467
- Sponsor's protocol ID
- 2022-0056
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho E, Wu Q, Rubinstein L, Linden H, Gralow J, Specht J, Gadi V, Ellis G. Adjuvant continuous metronomic adriamycin + cyclophosphamide followed by weekly nab-paclitaxel for high-risk early-stage breast cancer. Breast J. 2018 Jul;24(4):610-614. doi: 10.1111/tbj.13013. Epub 2018 Mar 13.
PubMed 29532546Robert N, Krekow L, Stokoe C, Clawson A, Iglesias J, O'Shaughnessy J. Adjuvant dose-dense doxorubicin plus cyclophosphamide followed by dose-dense nab-paclitaxel is safe in women with early-stage breast cancer: a pilot study. Breast Cancer Res Treat. 2011 Jan;125(1):115-20. doi: 10.1007/s10549-010-1187-2. Epub 2010 Oct 14.
PubMed 20945091
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Non-inferiority Study to Evaluate Injectable Albumin-bound Paclitaxel Versus Docetaxel for the Adjuvant Treatment of Breast Cancer
- ClinicalTrials.gov ID
- NCT05420467
- Acronym / sponsor ID
- 2022-0056
- Conditions
- Breast Cancer
- Keywords
- breast cancer, adjuvant therapy, Docetaxel, albumin paclitaxel, TCbHP, nPCbHP, ddEC-wnP, TC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,413 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 10 Jul 2022 (estimated)
- Primary completion
- 10 Jul 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 15 Jun 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.
Studies on postoperative adjuvant albumin paclitaxel in domestic breast cancer patients are less reported, especially in large samples, and more studies focus more on the safety and tolerability of albumin paclitaxel use. Head-to-head studies of white violet and docetaxel are not supported by data at this time, but some studies have shown that docetaxel-induced long-term Other adverse effects such as myelosuppression, hepatotoxicity and hypersensitivity reactions can have a serious impact on quality of life. Therefore, this study aims to analyse the efficacy and safety of albumin paclitaxel and docetaxel in the adjuvant treatment of breast cancer in a large randomized controlled trial, and to further analyse the efficacy and safety of albumin paclitaxel in combination with chemotherapy for postoperative breast cancer in different subtypes of breast cancer patients, in order to obtain more realistic data and provide new treatment options for breast cancer patients.
Detailed description
At present, the treatment of early-stage breast cancer is mainly surgical, supplemented by chemotherapy, endocrine therapy, radiotherapy, targeted therapy and other comprehensive treatment methods, through the use of a variety of comprehensive and individualized treatment plans led to a significant improvement in the quality of life and survival of breast cancer patients. Systematic adjuvant therapy after surgery is also gaining increasing attention, with a large number of randomized clinical trials worldwide . The effectiveness of adjuvant therapy in reducing the recurrence of breast cancer and improving survival has been demonstrated in a number of randomized clinical trials worldwide. Adjuvant therapy after surgery is recommended in NCCN guidelines, ESMO, St. Gallen and other guidelines or expert consensus.
The use of albumin paclitaxel in the postoperative adjuvant treatment of breast cancer has been reported overseas, and a phase II clinical study published in 2017 investigated the tolerability and feasibility of dose dense doxorubicin combined with cyclophosphamide followed by nab-paclitaxel (AC-nP) chemotherapy in patients with high-risk early-stage breast cancer in adjuvant treatment. The results suggested that this regimen was well tolerated, with an incidence of granular deficiency with fever 5 of 2%, suggesting the safety of weekly treatment with nab-paclitaxel.
Another study evaluated the safety of dose-dense AC-nP regimens in women with high-risk breast cancer. Enrolled patients received 4 cycles of AC (every 2 weeks) followed by nab-P (every 2 weeks). The most common eventual adverse reaction was peripheral neuropathy, although approximately 80% of patients were grade 1-2, and the patient's neuropathy gradually improved after the end of treatment. This suggests that in early breast cancer, the use of dose-dense AC followed by nab-P is feasible with predictable AEs .
In summary, studies on postoperative adjuvant albumin paclitaxel in domestic breast cancer patients are less reported, especially in large samples, and more studies focus more on the safety and tolerability of albumin paclitaxel use. Head-to-head studies of white violet and docetaxel are not supported by data at this time, but some studies have shown that docetaxel-induced long-term Other adverse effects such as myelosuppression, hepatotoxicity and hypersensitivity reactions can have a serious impact on quality of life. Therefore, this study aim to conduct a prospective, randomized, open-label, multi-center clinical study to analyse the efficacy and safety of albumin paclitaxel and docetaxel in the adjuvant treatment of breast cancer in a large randomized controlled trial, and to further analyse the efficacy and safety of albumin paclitaxel in combination with chemotherapy for postoperative breast cancer in different subtypes of breast cancer patients, in order to obtain more realistic data and provide new treatment options for breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| TCbHP | Active comparator | Drug: Docetaxel, Drug: Carboplatin, Drug: Trastuzumab, Drug: PertuzumabHER2-positive breast cancer |
| nPCbHP | Experimental | Drug: Carboplatin, Drug: Trastuzumab, Drug: Pertuzumab, Drug: Nab paclitaxelHER2-positive breast cancer |
| EC-T | Active comparator | Drug: Epirubicin, Drug: Cyclophosphamide, Drug: DocetaxelLuminal breast cancer (HER2-, more than 4 lymph node metastases), and triple negative breast cancer |
| ddEC-wnP | Experimental | Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Nab paclitaxelLuminal breast cancer (HER2-, more than 4 lymph node metastases), and triple negative breast cancer |
| TC | Active comparator | Drug: Docetaxel, Drug: CyclophosphamideLuminal breast cancer (HER2-, with 1-3 lymph nodes) |
| nPC | Experimental | Drug: Nab paclitaxel, Drug: CyclophosphamideLuminal breast cancer (HER2-, with 1-3 lymph nodes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Female patients aged ≥18 years;
- Histopathologically or cytologically confirmed breast cancer patients with the following characteristics:1. stage I to III breast cancer; 2. operable primary lesion with no evidence of distant metastasis (M0);
- known hormone receptor status (estrogen receptor [ER], progesterone receptor [PR]) and HER2 status with known Ki67 expression levels; (ER/PR positive defined as stained cells >1%, HER2 positive defined as IHC 3+ or IHC 2+ with a positive FISH test);
- Triple-negative breast cancer (TNBC): ER/PR negative, HER2 negative; tumor >2cm or lymph node metastasis with clear postoperative pathological evidence; Luminal breast cancer: ER>1%, HER2 negative, postoperative pathological evidence definite lymph node metastasis (different adjuvant chemotherapy regimens depending on whether the lymph nodes are N1 or N2-3); HER2-positive breast cancer: HER2-positive, regardless of ER/PR status; (the above classification determines enrollment and adjuvant therapy, and does not represent the corresponding molecular typing definition);
- Patients who have undergone breast cancer resection and systemic intrathoracic lymph node dissection; surgical resection is R0 resection; patients who need postoperative adjuvant chemotherapy as judged by the investigator;
Key exclusion criteria (15 listed)
- Advanced and/or inoperable patients with distant metastasis confirmed by imaging evidence or pathology;
- Other malignant tumors have occurred in the past 5 years, except for skin cancers of cured cervical carcinoma in situ and non-melanoma;
- Pregnant or breastfeeding women; patients with childbearing potential who are unwilling or unable to take effective contraceptive measures;
- The molecular status of ER/PR and HER2 and Ki67 cannot be determined;
- Patients with CNS metastases 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 |
|---|---|---|
| Docetaxel75 mg/m2, d1, q3w,6 cycles | Drug | TC, TCbHP |
| CarboplatinAUC 6, d1, q3w,6 cycles | Drug | TCbHP, nPCbHP |
| Trastuzumabstarting dose 8 mg/kg, maintenance dose 6 mg/kg, d1, q3w,6 cycles | Drug | TCbHP, nPCbHP |
| Pertuzumabstarting dose of 840 mg, maintenance dose of 420 mg, d1, q3w ,6 cycles | Drug | TCbHP, nPCbHP |
| Nab paclitaxel220 mg/m2, d1, q3w,6 cycles | Drug | nPC, nPCbHP |
| Epirubicin90 mg/m2, d1, q3w ,4 cycles ,followed by docetaxel | Drug | EC-T |
| Cyclophosphamide600 mg/m2, d1, q3w × 4 cycles followed by docetaxel | Drug | EC-T |
| Docetaxel100 mg/m2, d1, q3w × 4 cycles | Drug | EC-T |
| Epirubicin90 mg/m2,d1, q2w × 4 cycles followed by nab-paclitaxel | Drug | ddEC-wnP |
| Cyclophosphamide600 mg/m2, d1, q2w × 4 cycles followed by nab-paclitaxel | Drug | ddEC-wnP |
| Nab paclitaxel125 mg/m2, d1,8,15, q3w× 4 cycles | Drug | ddEC-wnP |
| Cyclophosphamide600 mg/m2, d1, q3w × 6 cycles | Drug | TC, nPC |
Primary outcome
5-year DFS
Time frame: 5-years
5-year disease-free survival
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Background: PubMed 29532546Cho E, Wu Q, Rubinstein L, Linden H, Gralow J, Specht J, Gadi V, Ellis G. Adjuvant continuous metronomic adriamycin + cyclophosphamide followed by weekly nab-paclitaxel for high-risk early-stage breast cancer. Breast J. 2018 Jul;24(4):610-614. doi: 10.1111/tbj.13013. Epub 2018 Mar 13.
- Background: PubMed 20945091Robert N, Krekow L, Stokoe C, Clawson A, Iglesias J, O'Shaughnessy J. Adjuvant dose-dense doxorubicin plus cyclophosphamide followed by dose-dense nab-paclitaxel is safe in women with early-stage breast cancer: a pilot study. Breast Cancer Res Treat. 2011 Jan;125(1):115-20. doi: 10.1007/s10549-010-1187-2. Epub 2010 Oct 14.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Docetaxel, Carboplatin and Trastuzumab in people with Breast Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 15 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 1 Jul 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yiding CHEN (13605719519, ydchen@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year DFS (time frame: 5-years). 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 NCT05420467, which also lists 2 linked publications.
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 1 Jul 2022.