Breast CancerPhase 4NCT05420454

A Study for the Neoadjuvant 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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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: 1,576 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;
unilateral primary invasive breast cancer that meets clinical diagnostic criteria and is histologically confirmed;
The tumor is >2cm, and the clinical stage is consistent with cT stage 2-4; or lymph node metastasis with clear clinical/pathological evidence;
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 neoadjuvant therapy, and does not represent the corresponding molecular typing definition);
patients who need neoadjuvant chemotherapy as judged by the investigator;

Show all 13Show fewer

ECOG physical fitness score of 0-1;
The patient has not received any treatment for breast cancer before enrollment;
Electrocardiogram (ECG) and echocardiography must confirm normal cardiac function within 3 months prior to randomization. Left ventricular ejection fraction (LVEF) must be ≥55%;
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 (where applicable).

Who cannot join

Advanced and/or inoperable patients with distant metastasis confirmed by imaging evidence or pathology;
Patients with bilateral invasive breast cancer;
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;

Show all 15Show fewer

Surgical axillary staging within 6 months prior to study entry;
Radiotherapy, chemotherapy, biotherapy and/or endocrine therapy for currently diagnosed breast cancer prior to study entry;
Patients with severe myelosuppression at screening;
Patients with severe liver dysfunction (Child's Class III) or renal dysfunction at screening ;
Other concomitant diseases (e.g. untreated congenital heart disease, glomerulonephritis, etc.) which, in the opinion of the investigator, seriously endanger the safety of the patient or would prevent the implementation or completion of the programme treatment;
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.

Yiding CHEN contact

Huihui CHEN contact

China1 site, 1 recruiting

2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Yiding Chen, 571-87784527, ydchen@zju.edu.cn
Recruiting

Other trials in China

About this study

Official title: A Prospective, Open-label Study to Evaluate Injectable Albumin-bound Paclitaxel Versus Docetaxel for the Neoadjuvant Treatment of Breast Cancer

Due to the unique advantages of albumin-bound paclitaxel, several studies in China and abroad have tried to use albumin-bound paclitaxel for neoadjuvant treatment of breast cancer up to now. However, comparative studies between paclitaxel and docetaxel are still rare, In this study, a prospective, randomized, open-label, multi-center clinical study was conducted to analyse the efficacy and safety of albumin-bound paclitaxel and docetaxel in the neoadjuvant treatment of breast cancer, 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

Neoadjuvant chemotherapy refers to systemic chemotherapy as the first step for treating breast cancer patients before planned local treatment like surgery for those without distant metastasis. It is reported that preoperative neoadjuvant chemotherapy can facilitate breast conservation, render inoperable tumors operable and provide important prognostic information at an individual patient level based on response to therapy.

Previous studies have confirmed that the efficacy of albumin-bound paclitaxel in neoadjuvant therapy and was well tolerated when combined with sequential chemotherapy with anthracyclines .

The GBG69 study was the first to compare the efficacy and safety of nab-paclitaxel (nab-P) and solvent-based paclitaxel in the neoadjuvant treatment of breast cancer. The results showed that the pCR rate in the nab-P group was significantly higher than that in the solvent paclitaxel group (38% vs 29% p<0.001). Long-term follow-up results showed that after 4 years, iDFS was also significantly improved in nab-P-treated patients compared with solvent paclitaxel (84.0% vs 76.3%; HR, 0.66; 95% CI, 0.51-0.86; P = 0.0023).

Another phase II study compared docetaxel and albumin paclitaxel in neoadjuvant chemotherapy for HER2-negative early-stage breast cancer. The results showed a slightly higher pCR rate in the nab-P group (docetaxel: 12%; nab-P: 17%). In the Ki67>20% subgroup, the pCR rates were 16% (docetaxel) vs 24% (nab-P) respectively. demonstrating that albumin-bound paclitaxel (nab-P) appears to demonstrate greater efficacy in breast cancer compared to docetaxel.

However, comparative studies between paclitaxel and docetaxel are still rare, In this study, a prospective, randomized, open-label, multi-center clinical study was conducted to analyse the efficacy and safety of albumin-bound paclitaxel and docetaxel in the neoadjuvant treatment of breast cancer, 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, neoadjuvant therapy, Docetaxel, albumin-bound paclitaxel, TCbHP, nPCbHP, ddEC-wnP, 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

Study groups in NCT05420454
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-, LN+), and triple negative breast cancer Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel
ddEC-wnP	Experimental	Luminal breast cancer (HER2-, LN+), and triple negative breast cancer Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Nab paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

pCR(pathological complete response)
defined as ypT0/is, ypN0 (defined as no invasive tumor in breast and axillary lymph nodes
Measured: 1year

Secondary outcomes (4)

OS
overall survival
Measured: 10 years
DFS
disease-free survival
Measured: 2 years
DMFS
distant metastasis-free survival
Measured: 2 years
Secondary pCR
defined as ypT0, ypN0 (no invasive or residual carcinoma in situ lesions in breast and axillary lymph nodes
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 202220 Dec 2027

First posted15 Jun 2022
Study start10 Jul 2022 (estimated)
Primary completion10 Jun 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 (5)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: 1,576 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05420454
Sponsor's protocol ID: 2022-0055
Status last verified: Jun 2022
First submitted: 12 Jun 2022
Last updated: 1 Jul 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Robidoux A, Buzdar AU, Quinaux E, Jacobs S, Rastogi P, Fourchotte V, Younan RJ, Pajon ER, Shalaby IA, Desai AM, Fehrenbacher L, Geyer CE Jr, Mamounas EP, Wolmark N. A phase II neoadjuvant trial of sequential nanoparticle albumin-bound paclitaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide in locally advanced breast cancer. Clin Breast Cancer. 2010 Feb;10(1):81-6. doi: 10.3816/CBC.2010.n.011.
PubMed 20133263
Shimada H, Ueda S, Saeki T, Shigekawa T, Takeuchi H, Hirokawa E, Sugitani I, Sugiyama M, Takahashi T, Matsuura K, Yamane T, Kuji I, Hasebe T, Osaki A. Neoadjuvant triweekly nanoparticle albumin-bound paclitaxel followed by epirubicin and cyclophosphamide for Stage II/III HER2-negative breast cancer: evaluation of efficacy and safety. Jpn J Clin Oncol. 2015 Jul;45(7):642-9. doi: 10.1093/jjco/hyv055. Epub 2015 May 19.
PubMed 25989989
Untch M, Jackisch C, Schneeweiss A, Conrad B, Aktas B, Denkert C, Eidtmann H, Wiebringhaus H, Kummel S, Hilfrich J, Warm M, Paepke S, Just M, Hanusch C, Hackmann J, Blohmer JU, Clemens M, Darb-Esfahani S, Schmitt WD, Dan Costa S, Gerber B, Engels K, Nekljudova V, Loibl S, von Minckwitz G; German Breast Group (GBG); Arbeitsgemeinschaft Gynakologische Onkologie-Breast (AGO-B) Investigators. Nab-paclitaxel versus solvent-based paclitaxel in neoadjuvant chemotherapy for early breast cancer (GeparSepto-GBG 69): a randomised, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):345-356. doi: 10.1016/S1470-2045(15)00542-2. Epub 2016 Feb 8.
PubMed 26869049
Untch M, Jackisch C, Schneeweiss A, Schmatloch S, Aktas B, Denkert C, Schem C, Wiebringhaus H, Kummel S, Warm M, Fasching PA, Just M, Hanusch C, Hackmann J, Blohmer JU, Rhiem K, Schmitt WD, Furlanetto J, Gerber B, Huober J, Nekljudova V, von Minckwitz G, Loibl S. NAB-Paclitaxel Improves Disease-Free Survival in Early Breast Cancer: GBG 69-GeparSepto. J Clin Oncol. 2019 Sep 1;37(25):2226-2234. doi: 10.1200/JCO.18.01842. Epub 2019 May 13.
PubMed 31082269
Kuwayama T, Nakamura S, Hayashi N, Takano T, Tsugawa K, Sato T, Kitani A, Okuyama H, Yamauchi H. Randomized Multicenter Phase II Trial of Neoadjuvant Therapy Comparing Weekly Nab-paclitaxel Followed by FEC With Docetaxel Followed by FEC in HER2- Early-stage Breast Cancer. Clin Breast Cancer. 2018 Dec;18(6):474-480. doi: 10.1016/j.clbc.2018.06.012. Epub 2018 Jun 27.
PubMed 30072191

Interested in taking part?

Yiding CHEN

13605719519

ydchen@zju.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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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 Study to Evaluate Injectable Albumin-bound Paclitaxel Versus Docetaxel for the Neoadjuvant Treatment of Breast Cancer
ClinicalTrials.gov ID: NCT05420454
Acronym / sponsor ID: 2022-0055
Conditions: Breast Cancer
Keywords: breast cancer, neoadjuvant therapy, Docetaxel, albumin-bound paclitaxel, TCbHP, nPCbHP, ddEC-wnP, EC-T
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 1,576 participants (estimated)
Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
Study start: 10 Jul 2022 (estimated)
Primary completion: 10 Jun 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.

Detailed description

Previous studies have confirmed that the efficacy of albumin-bound paclitaxel in neoadjuvant therapy and was well tolerated when combined with sequential chemotherapy with anthracyclines .

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

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-, LN+), and triple negative breast cancer
ddEC-wnP	Experimental	Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Nab paclitaxelLuminal breast cancer (HER2-, LN+), and triple negative breast cancer

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Female patients aged ≥18 years;
unilateral primary invasive breast cancer that meets clinical diagnostic criteria and is histologically confirmed;
The tumor is >2cm, and the clinical stage is consistent with cT stage 2-4; or lymph node metastasis with clear clinical/pathological evidence;
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 neoadjuvant therapy, and does not represent the corresponding molecular typing definition);

Key exclusion criteria (15 listed)

Advanced and/or inoperable patients with distant metastasis confirmed by imaging evidence or pathology;
Patients with bilateral invasive breast cancer;
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;

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	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	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

Primary outcome

pCR(pathological complete response)
Time frame: 1year
defined as ypT0/is, ypN0 (defined as no invasive tumor in breast and axillary lymph nodes

4 secondary outcomes

OS
Time frame: 10 years
DFS
Time frame: 2 years
DMFS
Time frame: 2 years
Secondary pCR
Time frame: 1 year

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 20133263Robidoux A, Buzdar AU, Quinaux E, Jacobs S, Rastogi P, Fourchotte V, Younan RJ, Pajon ER, Shalaby IA, Desai AM, Fehrenbacher L, Geyer CE Jr, Mamounas EP, Wolmark N. A phase II neoadjuvant trial of sequential nanoparticle albumin-bound paclitaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide in locally advanced breast cancer. Clin Breast Cancer. 2010 Feb;10(1):81-6. doi: 10.3816/CBC.2010.n.011.
Background: PubMed 25989989Shimada H, Ueda S, Saeki T, Shigekawa T, Takeuchi H, Hirokawa E, Sugitani I, Sugiyama M, Takahashi T, Matsuura K, Yamane T, Kuji I, Hasebe T, Osaki A. Neoadjuvant triweekly nanoparticle albumin-bound paclitaxel followed by epirubicin and cyclophosphamide for Stage II/III HER2-negative breast cancer: evaluation of efficacy and safety. Jpn J Clin Oncol. 2015 Jul;45(7):642-9. doi: 10.1093/jjco/hyv055. Epub 2015 May 19.
Background: PubMed 26869049Untch M, Jackisch C, Schneeweiss A, Conrad B, Aktas B, Denkert C, Eidtmann H, Wiebringhaus H, Kummel S, Hilfrich J, Warm M, Paepke S, Just M, Hanusch C, Hackmann J, Blohmer JU, Clemens M, Darb-Esfahani S, Schmitt WD, Dan Costa S, Gerber B, Engels K, Nekljudova V, Loibl S, von Minckwitz G; German Breast Group (GBG); Arbeitsgemeinschaft Gynakologische Onkologie-Breast (AGO-B) Investigators. Nab-paclitaxel versus solvent-based paclitaxel in neoadjuvant chemotherapy for early breast cancer (GeparSepto-GBG 69): a randomised, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):345-356. doi: 10.1016/S1470-2045(15)00542-2. Epub 2016 Feb 8.
Background: PubMed 31082269Untch M, Jackisch C, Schneeweiss A, Schmatloch S, Aktas B, Denkert C, Schem C, Wiebringhaus H, Kummel S, Warm M, Fasching PA, Just M, Hanusch C, Hackmann J, Blohmer JU, Rhiem K, Schmitt WD, Furlanetto J, Gerber B, Huober J, Nekljudova V, von Minckwitz G, Loibl S. NAB-Paclitaxel Improves Disease-Free Survival in Early Breast Cancer: GBG 69-GeparSepto. J Clin Oncol. 2019 Sep 1;37(25):2226-2234. doi: 10.1200/JCO.18.01842. Epub 2019 May 13.
Background: PubMed 30072191Kuwayama T, Nakamura S, Hayashi N, Takano T, Tsugawa K, Sato T, Kitani A, Okuyama H, Yamauchi H. Randomized Multicenter Phase II Trial of Neoadjuvant Therapy Comparing Weekly Nab-paclitaxel Followed by FEC With Docetaxel Followed by FEC in HER2- Early-stage Breast Cancer. Clin Breast Cancer. 2018 Dec;18(6):474-480. doi: 10.1016/j.clbc.2018.06.012. Epub 2018 Jun 27.

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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.

Yiding CHEN contact

Huihui CHEN contact

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 13 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?

pCR(pathological complete response) (time frame: 1year). 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 NCT05420454, which also lists 5 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.