Triple-Negative Breast CancerPhase 2NCT03154749
DCb (Docetaxel/Carboplatin) Versus EC-D (Epirubicin/Cyclophosphamide Followed by Docetaxe) as Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer
A Phase 2 study testing DCb (docetaxel/carboplatin) versus EC followed by D (epirubicin/cyclophosphamide followed by docetaxe) in people with Triple-Negative Breast Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Both DCb (docetaxel/carboplatin) and EC followed by D (epirubicin/cyclophosphamide followed by docetaxe) regimens as Neoadjuvant Treatment for Triple-Negative Breast Cancer have been recommended by NCCN guideline. It is unknown which regimen is better. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Triple-Negative Breast Cancer
- What is being tested?
- DCb (docetaxel/carboplatin) versus EC followed by D (epirubicin/cyclophosphamide followed by docetaxe)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2016to 31 Dec 2019
- Phase
- Phase 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
None listed.
Who cannot join
- Patients who meet any of the following criteria will be excluded from study entry:
- Stage IV (metastatic) breast cancer
- Patients with a history of invasive breast cancer.
- Patients with a history of ductal carcinoma in situ (DCIS), except for patients treated exclusively with mastectomy > 5 years prior to diagnosis of current breast cancer
- Patients with bilateral breast cancer
- Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer.
Show all 11Show fewer
- Patients who have undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
- History of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain disease free for greater than five years are eligible.
- Current severe, uncontrolled systemic disease that may interfere with planned treatment (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound-healing disorders)
- Major surgical procedure unrelated to breast cancer or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
- Current pregnancy and/or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Docetaxel + Carboplatin Versus Epirubicin+Cyclophosphamide Followed by Docetaxel in Triple-Negative, Early-Stage Breast Cancer (NeoCART): Study Protocol for a Multicenter, Randomized Controlled, Open-Label, Phase 2 Trial
Both DCb (docetaxel/carboplatin) and EC followed by D (epirubicin/cyclophosphamide followed by docetaxe) regimens as Neoadjuvant Treatment for Triple-Negative Breast Cancer have been recommended by NCCN guideline. It is unknown which regimen is better. This study is to evaluate the efficacy and safety of DCb (docetaxel/carboplatin) and EC followed by D(epirubicin/cyclophosphamide followed by docetaxe) regimens as Neoadjuvant Treatment in Triple-Negative breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.
Read the detailed description
Triple negative breast cancer (TNBC) is a subtype lacking estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor type 2 (HER2) amplification. TNBC accounts for 15-20% of all invasive breast cancer. Although PARP inhibitors and immunotherapy may play a role in the treatment of early TNBC, the mainstay of treatment for TNBC is cytotoxic chemotherapy. However, despite its sensitivity to chemotherapy, TNBC is still associated with a poor prognosis.
TNBC is usually recommended for neoadjuvant therapy. The benefits of neoadjuvant therapy include reducing the size of the tumor to suit breast conserving surgery, avoiding axillary lymph node dissection, making inoperable tumors operable, and obtaining an in vivo evaluation of the tumor's chemosensitivity. Taxane- and anthracycline-based neoadjuvant regimens have become a standard treatment for TNBC, and patients have been proved to have better event-free survival (EFS) and overall survival (OS) who achieve a pathologic complete response (pCR) after neoadjuvant chemotherapy1.
Carboplatin attack cancer cells by inducing double-stranded DNA breaks, and TNBC may be sensitive to carboplatin2. Previous studies have shown that adding carboplatin to neoadjuvant chemotherapy regimens significantly improved pCR rate in TNBC patients3, 4.
Due to the long-term cardiotoxicity caused by anthracycline, several studies have explored the efficacy of neoadjuvant paclitaxel plus carboplatin regimens in TNBC and have achieved satisfactory pCR rates, but there are still controversies5. However, there is no study making comparisons between the combination of taxanes and carboplatin without anthracycline and the standard neoadjuvant regimens. Whether the combination of taxanes and carboplatin without anthracycline can achieve better efficacy while reducing adverse reactions still needs to be explored.
The NeoCART study was designed to compare the efficacy and safety of docetaxel plus carboplatin with standard neoadjuvant chemotherapy in TNBC.
- Conditions
- Triple-Negative Breast Cancer
- Being tested
- DCb (docetaxel/carboplatin) versus EC followed by D (epirubicin/cyclophosphamide followed by docetaxe)
- Keywords
- Neoadjuvant chemotherapy, Triple-Negative Breast Cancer
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCb (docetaxel/carboplatin) versus EC followed by D (epirubicin/cyclophosphamide followed by docetaxe)Drug
All eligible patients were randomly assigned at a 1:1 ratio to the experimental arm (docetaxel (75 mg/m2 administered intravenously every 3 weeks) plus carboplatin (AUC 6 mg/mL per min, intravenously every 3 weeks) for six cycles) or the standard treatment arm (epirubicin (90 mg/m2) plus cyclophosphamide (600 mg/m2), both administered intravenously every 3 weeks for four cycles, followed by docetaxel (100 mg/m2) administered intravenously every 3 weeks for four cycles).
| Study group | Role | What they receive |
|---|---|---|
| DCb | Experimental | Docetaxel (75 mg/m2 administered intravenously every 3 weeks) and carboplatin (area under the concentration-time curve [AUC] 6, intravenously every 3 weeks) for six cycles Receives: Drug: DCb (docetaxel/carboplatin) versus EC followed by D (epirubicin/cyclophosphamide followed by docetaxe) |
| EC-D | Active comparator | Epirubicin (90 mg/m2) plus cyclophosphamide (600 mg/m2), both administered intravenously every 3 weeks for four cycles, followed by docetaxel (100 mg/m2) administered intravenously every 3 weeks for four cycles Receives: Drug: DCb (docetaxel/carboplatin) versus EC followed by D (epirubicin/cyclophosphamide followed by docetaxe) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR
Local evaluation of pCR defined as the absence of any residual invasive cancer of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/is, ypN0 in the current AJCC staging system)
Measured: Up to approximately 27-30 weeks
Secondary outcomes (4)
Breast-conserving surgery rate
defined as the proportion of patients who achieved breast-conserving surgery out of the intent-to-treat (ITT) population of patients without inflammatory breast cancer
Measured: Up to approximately 27-30 weeks
EFS
defined as time from randomization to disease progression, disease recurrence (local, regional, distant, or contralateral [invasive or non-invasive]), or death from any cause
Measured: Up to approximately 36 months
OS
defined as the time from randomization to death from any cause
Measured: Up to approximately 36 months
Adverse events
Incidence, type, and severity of all adverse events (including serious adverse events) based on NCI CTCAE, v4.0.
Measured: Up to approximately 27-30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 Sep 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Triple-Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shantou Central Hospital, First Affiliated Hospital, Sun Yat-Sen University, Henan Cancer Hospital, Dongguan People's Hospital, Baotou Cancer Hospital
- Responsible party
- Principal investigator, Kun Wang, Guangdong Provincial People's Hospital
- Investigators
- Wang Kun, MD, Study chair, Study Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154749
- Sponsor's protocol ID
- 20170512
- Status last verified
- Aug 2022
- First submitted
- 12 May 2017
- Last updated
- 1 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu T, Huang YH, Li W, Wu CG, Zhang YM, Zheng XX, Zhang TF, Lin YY, Liu ZY, Ye GL, Lin Y, Wu ZY, Wang K. A non-invasive artificial intelligence model for identifying axillary pathological complete response to neoadjuvant chemotherapy in breast cancer: a secondary analysis to multicenter clinical trial. Br J Cancer. 2024 Sep;131(4):692-701. doi: 10.1038/s41416-024-02726-3. Epub 2024 Jun 25.
PubMed 38918556Yang C, Li P, Chen Y, Zheng J, Zhang X, Gao HF, Zhang L, Wang K. Pooled analysis of NeoCARH and NeoCART trials: patient-reported outcomes in patients with early-stage breast cancer receiving platinum-based or anthracycline-based neoadjuvant chemotherapy. Support Care Cancer. 2024 Jun 3;32(6):401. doi: 10.1007/s00520-024-08610-3.
PubMed 38829506Zhang L, Wu Z, Li J, Zhu D, Yang L, Shao Y, Lin Y, Liu Z, Cao Y, Zhang G, Shang S, Zhang Y, Wang K. Impact of Homologous Recombination Deficiency on Outcomes in Patients With Triple-Negative Breast Cancer Treated With Carboplatin-Based Neoadjuvant Chemotherapy: Secondary Analysis of the NeoCART Randomized Clinical Trial. JCO Precis Oncol. 2023 Jan;7:e2200337. doi: 10.1200/PO.22.00337.
PubMed 36652665Li WP, Zhu T, Hu MX, Yang M, Ji F, Gao HF, Yang CQ, Zhang LL, Cheng MY, Xu FP, Wang K. Comparison of the efficacy and safety of the EC-T (epirubicin/cyclophosphamide followed by docetaxel) and TCb (docetaxel/carboplatin) neoadjuvant regimens in early TOP2A-normal stage II-III breast cancer. Neoplasma. 2020 Nov;67(6):1409-1415. doi: 10.4149/neo_2020_200130N96. Epub 2020 Jul 13.
PubMed 32657611
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Docetaxel + Carboplatin Versus Epirubicin+Cyclophosphamide Followed by Docetaxel in Triple-Negative, Early-Stage Breast Cancer (NeoCART): Study Protocol for a Multicenter, Randomized Controlled, Open-Label, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT03154749
- Acronym / sponsor ID
- 20170512
- Conditions
- Triple-Negative Breast Cancer
- Keywords
- Neoadjuvant chemotherapy, Triple-Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Shantou Central Hospital, First Affiliated Hospital, Sun Yat-Sen University, Henan Cancer Hospital, Dongguan People's Hospital, Baotou Cancer Hospital
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 16 May 2017 (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.
Both DCb (docetaxel/carboplatin) and EC followed by D (epirubicin/cyclophosphamide followed by docetaxe) regimens as Neoadjuvant Treatment for Triple-Negative Breast Cancer have been recommended by NCCN guideline. It is unknown which regimen is better. This study is to evaluate the efficacy and safety of DCb (docetaxel/carboplatin) and EC followed by D(epirubicin/cyclophosphamide followed by docetaxe) regimens as Neoadjuvant Treatment in Triple-Negative breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.
Detailed description
Triple negative breast cancer (TNBC) is a subtype lacking estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor type 2 (HER2) amplification. TNBC accounts for 15-20% of all invasive breast cancer. Although PARP inhibitors and immunotherapy may play a role in the treatment of early TNBC, the mainstay of treatment for TNBC is cytotoxic chemotherapy. However, despite its sensitivity to chemotherapy, TNBC is still associated with a poor prognosis.
TNBC is usually recommended for neoadjuvant therapy. The benefits of neoadjuvant therapy include reducing the size of the tumor to suit breast conserving surgery, avoiding axillary lymph node dissection, making inoperable tumors operable, and obtaining an in vivo evaluation of the tumor's chemosensitivity. Taxane- and anthracycline-based neoadjuvant regimens have become a standard treatment for TNBC, and patients have been proved to have better event-free survival (EFS) and overall survival (OS) who achieve a pathologic complete response (pCR) after neoadjuvant chemotherapy1.
Carboplatin attack cancer cells by inducing double-stranded DNA breaks, and TNBC may be sensitive to carboplatin2. Previous studies have shown that adding carboplatin to neoadjuvant chemotherapy regimens significantly improved pCR rate in TNBC patients3, 4.
Due to the long-term cardiotoxicity caused by anthracycline, several studies have explored the efficacy of neoadjuvant paclitaxel plus carboplatin regimens in TNBC and have achieved satisfactory pCR rates, but there are still controversies5. However, there is no study making comparisons between the combination of taxanes and carboplatin without anthracycline and the standard neoadjuvant regimens. Whether the combination of taxanes and carboplatin without anthracycline can achieve better efficacy while reducing adverse reactions still needs to be explored.
The NeoCART study was designed to compare the efficacy and safety of docetaxel plus carboplatin with standard neoadjuvant chemotherapy in TNBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCb | Experimental | Drug: DCb (docetaxel/carboplatin) versus EC followed by D (epirubicin/cyclophosphamide followed by docetaxe)Docetaxel (75 mg/m2 administered intravenously every 3 weeks) and carboplatin (area under the concentration-time curve [AUC] 6, intravenously every 3 weeks) for six cycles |
| EC-D | Active comparator | Drug: DCb (docetaxel/carboplatin) versus EC followed by D (epirubicin/cyclophosphamide followed by docetaxe)Epirubicin (90 mg/m2) plus cyclophosphamide (600 mg/m2), both administered intravenously every 3 weeks for four cycles, followed by docetaxel (100 mg/m2) administered intravenously every 3 weeks for four cycles |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Stage IV (metastatic) breast cancer
- Patients with a history of invasive breast cancer.
- Patients with a history of ductal carcinoma in situ (DCIS), except for patients treated exclusively with mastectomy > 5 years prior to diagnosis of current breast cancer
- Patients with bilateral breast cancer
- Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer.
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 |
|---|---|---|
| DCb (docetaxel/carboplatin) versus EC followed by D (epirubicin/cyclophosphamide followed by docetaxe)All eligible patients were randomly assigned at a 1:1 ratio to the experimental arm (docetaxel (75 mg/m2 administered intravenously every 3 weeks) plus carboplatin (AUC 6 mg/mL per min, intravenously every 3 weeks) for six cycles) or the standard treatment arm (epirubicin (90 mg/m2) plus cyclophosphamide (600 mg/m2), both administered intravenously every 3 weeks for four cycles, followed by docetaxel (100 mg/m2) administered intravenously every 3 weeks for four cycles). | Drug | DCb, EC-D |
Primary outcome
PCR
Time frame: Up to approximately 27-30 weeks
Local evaluation of pCR defined as the absence of any residual invasive cancer of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/is, ypN0 in the current AJCC staging system)
4 secondary outcomes
Breast-conserving surgery rate
Time frame: Up to approximately 27-30 weeks
EFS
Time frame: Up to approximately 36 months
OS
Time frame: Up to approximately 36 months
Adverse events
Time frame: Up to approximately 27-30 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Derived from this study: PubMed 38918556Zhu T, Huang YH, Li W, Wu CG, Zhang YM, Zheng XX, Zhang TF, Lin YY, Liu ZY, Ye GL, Lin Y, Wu ZY, Wang K. A non-invasive artificial intelligence model for identifying axillary pathological complete response to neoadjuvant chemotherapy in breast cancer: a secondary analysis to multicenter clinical trial. Br J Cancer. 2024 Sep;131(4):692-701. doi: 10.1038/s41416-024-02726-3. Epub 2024 Jun 25.
- Derived from this study: PubMed 38829506Yang C, Li P, Chen Y, Zheng J, Zhang X, Gao HF, Zhang L, Wang K. Pooled analysis of NeoCARH and NeoCART trials: patient-reported outcomes in patients with early-stage breast cancer receiving platinum-based or anthracycline-based neoadjuvant chemotherapy. Support Care Cancer. 2024 Jun 3;32(6):401. doi: 10.1007/s00520-024-08610-3.
- Derived from this study: PubMed 36652665Zhang L, Wu Z, Li J, Zhu D, Yang L, Shao Y, Lin Y, Liu Z, Cao Y, Zhang G, Shang S, Zhang Y, Wang K. Impact of Homologous Recombination Deficiency on Outcomes in Patients With Triple-Negative Breast Cancer Treated With Carboplatin-Based Neoadjuvant Chemotherapy: Secondary Analysis of the NeoCART Randomized Clinical Trial. JCO Precis Oncol. 2023 Jan;7:e2200337. doi: 10.1200/PO.22.00337.
- Derived from this study: PubMed 32657611Li WP, Zhu T, Hu MX, Yang M, Ji F, Gao HF, Yang CQ, Zhang LL, Cheng MY, Xu FP, Wang K. Comparison of the efficacy and safety of the EC-T (epirubicin/cyclophosphamide followed by docetaxel) and TCb (docetaxel/carboplatin) neoadjuvant regimens in early TOP2A-normal stage II-III breast cancer. Neoplasma. 2020 Nov;67(6):1409-1415. doi: 10.4149/neo_2020_200130N96. Epub 2020 Jul 13.
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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.
Wang Kun, MD study chair
Study Chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DCb (docetaxel/carboplatin) versus EC followed by D (epirubicin/cyclophosphamide followed by docetaxe) in people with Triple-Negative Breast Cancer, run by Guangdong Provincial People's Hospital 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 0 inclusion and 11 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: finished, as of the sponsor's last update on 1 Sep 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PCR (time frame: Up to approximately 27-30 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 NCT03154749, which also lists 4 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 Sep 2022.