Breast NeoplasmPhase 3TCTNNCT02455141

Adjuvant Treatment of EC Followed by Taxane +/- Carboplatin in Triple-Negative Breast Cancer

A Phase 3 study testing Epirubicin plus Cyclophosphamide, Taxanes and Taxanes plus Carboplatin in people with Breast Neoplasm, run by Shanghai Jiao Tong University School of Medicine at 27 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

To compare disease-free survival (DFS) rate of adjuvant chemotherapy epirubicin-cyclophosphamide followed by weekly paclitaxel or docetaxel (EC-T), or weekly paclitaxel or docetaxel-carboplatin (EC-TCb) in triple-negative breast cancer. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Breast Neoplasm
What is being tested?: Epirubicin plus Cyclophosphamide, Taxanes and Taxanes plus Carboplatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 786 participants
Where: 27 sitesChina
Study dates: Mar 2016to Mar 2030
Phase: Phase 3
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 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed adenocarcinoma of the breast, completely tumor removal by either modified radical mastectomy or local excision plus axillary lymph node dissection (i.e., breast conservation therapy) or sentinel node biopsy. (Tumor-free margins at least 1 mm for both invasive and noninvasive carcinoma except for lobular carcinoma in situ (less than 1 mm allowed);
Tumor specimens are available for estrogen receptor (ER), progesterone receptor (PgR) and Her2 (human epidermal-growth-factor receptor 2) detection, patients should be with triple negative breast cancer. Triple-negative disease is defined as ER <10% positivity, PgR <10% positivity, and negativity for Her2 (IHC (immunohistochemistry) 0-1+ or FISH (fluorescence in situ hybridization) negative);
Adequate bone marrow function
Adequate liver and renal function
Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1;
Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study;
Written informed consent according to the local ethics committee requirements.

Who cannot join

Prior systemic of breast cancer, including chemotherapy;
Metastatic breast cancer;
With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma;
Patients with medical conditions that indicate intolerant to adjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitus, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease;
Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive;
Contraindication for using dexamethasone;

Show all 12Show fewer

History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP>180 mmHg or diastolic BP>100 mmHg);
Has peripheral neuropathy no less than grade 1;
Patient is pregnant or breast feeding;
Patients with psychiatric disorder or other diseases leading to incompliance to the therapy;
Known severe hypersensitivity to any drugs in this study;
Treatment with any investigational drugs within 30 days before the beginning of study treatment.

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

China27 sites

Foshan No.1 People's Hospital
Foshan, Guangdong, 528000
Fuding Hospital
Fuding, Fujian
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Guangdong Maternal and Child Health Care Hospital
Guangzhou, Guangdong, 510000
Hangzhou Cancer Hospital
Hangzhou, Zhejiang
Zhejiang Provincial Hospital of TCM
Hangzhou, Zhejiang
Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, 150081
Jiangsu Jiangyin People's Hospital
Jiangyin, Jiangsu, 214400
Jiaxin Maternal and Child Health Care Hospital
Jiaxin, Zhejiang, 310000
Lishui People's Hospital
Lishui, Zhejiang, 310000
Ningbo Medical Treatment Center Lihuili Hospital
Ningbo, Zhejiang, 315000
Ningbo Women and Children's Hospital
Ningbo, Zhejiang, 315000
Ningbo First Hospital
Ningbo, Zhejiang
Quanzhou First Hospital
Quanzhou, Fujian
Rui'an People's Hospital
Rui’an, Zhejiang, 325200
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200021
Shanghai JiaoTong University School of Medicine, Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Central Hospital of Huangpu District, Shanghai
Shanghai, Shanghai Municipality
Shanghai International Peace Maternal and child health care hospital
Shanghai, Shanghai Municipality
The Ninth People's Hospital of Shanghai
Shanghai, Shanghai Municipality
Shaoxing Shangyu People's Hospital
Shaoxing, Zhejiang, 312300
Shaoxing No.2 Hospital
Shaoxing, Zhejiang
The First People's Hospital of Wujiang District
Suzhou, Jiangsu, 215200
Taizhou Central Hospital
Taizhou, Zhejiang, 318000
Wenzhou People's Hospital
Wenzhou, Zhejiang
Yancheng Hospital of TCM
Yancheng, Jiangsu
Zhoushan Hospital
Zhoushan, Zhejiang, 316000

Other trials in China

About this study

Official title: Epirubicin-Cyclophosphamide Followed by Taxanes or Taxanes Plus Carboplatin in Triple-Negative Breast Cancer：A Prospective, Randomized, Phase III Trial

Read the detailed description

This study plans to enroll triple-negative breast cancer patients who have complete tumor removal. Patients are randomized to receive either EC-wP/T or EC-wP/TCb adjuvant chemotherapy. For triple-negative breast cancer, a subgroup of triple-negative breast cancer has DNA repairement deficiency and adding carboplatin to paclitaxel may improve DFS on the basis of weekly paclitaxel adjuvant chemotherapy.

Conditions: Breast Neoplasm
Being tested: Epirubicin plus Cyclophosphamide, Taxanes, Taxanes plus Carboplatin
Keywords: chemptherapy, triple negative, taxanes, carboplatin
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Epirubicin plus CyclophosphamideDrug
Also called EC
Epirubicin 90mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4
TaxanesDrug
Paclitaxel: 80mg/m2, d1, qw*12 or Docetaxel: 80-100mg/m2,d1,q3w*4
Taxanes plus CarboplatinDrug
Paclitaxel: 80mg/m2, d1,d8,d15, q4w*4 Carboplatin AUC=2, d1,d8,d15, q4w*4 or Docetaxel: 75mg/m2,d1,q3w*4 plus Carboplatin AUC=5-6, d1, q3w*4

Study groups in NCT02455141
Study group	Role	What they receive
Taxanes	Active comparator	Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel Receives: Drug: Epirubicin plus Cyclophosphamide; Drug: Taxanes
Taxanes plus carboplatin	Experimental	Epirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel + Carboplatin Receives: Drug: Epirubicin plus Cyclophosphamide; Drug: Taxanes plus Carboplatin

What is being measured

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

Disease-free survival
The time from randomization to local or regional recurrence, distant metastases, other non-breast secondary primary malignancies, contralateral breast cancer, or death due to any cause, whichever occurs first.
Measured: From time of randomization to 5 years after enrollment.

Secondary outcomes (3)

Distant disease-free survival
The time from randomization to distant metastases, other non-breast secondary primary malignancies, or death due to any cause, whichever occurs first.
Measured: From time of randomization to 5 years after enrollment.
Overall Survival
The time from randomization to death due to any cause.
Measured: From time of randomization to 5 years after enrollment.
Incidence of adverse events
To compare the grade 3-5 adverse events among two treatment arms according to the NCI-CTCAE v4.0 criteria.
Measured: From randomization to four weeks after end of study treatment

Timeline

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

Mar 2016Mar 2030

First posted27 May 2015 (estimated)
Study startMar 2016
Primary completionMar 2027 (estimated)
Study completionMar 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Breast NeoplasmStudies of the same condition, open and under way.
More trials run by Shanghai Jiao Tong 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 786 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02455141
Sponsor's protocol ID: RJBC1501
Acronym: TCTN
Status last verified: Jul 2025
First submitted: 2 May 2015
Last updated: 11 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Hayes DF, Thor AD, Dressler LG, Weaver D, Edgerton S, Cowan D, Broadwater G, Goldstein LJ, Martino S, Ingle JN, Henderson IC, Norton L, Winer EP, Hudis CA, Ellis MJ, Berry DA; Cancer and Leukemia Group B (CALGB) Investigators. HER2 and response to paclitaxel in node-positive breast cancer. N Engl J Med. 2007 Oct 11;357(15):1496-506. doi: 10.1056/NEJMoa071167.
PubMed 17928597
Martin M, Rodriguez-Lescure A, Ruiz A, Alba E, Calvo L, Ruiz-Borrego M, Santaballa A, Rodriguez CA, Crespo C, Abad M, Dominguez S, Florian J, Llorca C, Mendez M, Godes M, Cubedo R, Murias A, Batista N, Garcia MJ, Caballero R, de Alava E. Molecular predictors of efficacy of adjuvant weekly paclitaxel in early breast cancer. Breast Cancer Res Treat. 2010 Aug;123(1):149-57. doi: 10.1007/s10549-009-0663-z.
PubMed 20037779
Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance). J Clin Oncol. 2015 Jan 1;33(1):13-21. doi: 10.1200/JCO.2014.57.0572. Epub 2014 Aug 4.
PubMed 25092775
von Minckwitz G, Schneeweiss A, Loibl S, Salat C, Denkert C, Rezai M, Blohmer JU, Jackisch C, Paepke S, Gerber B, Zahm DM, Kummel S, Eidtmann H, Klare P, Huober J, Costa S, Tesch H, Hanusch C, Hilfrich J, Khandan F, Fasching PA, Sinn BV, Engels K, Mehta K, Nekljudova V, Untch M. Neoadjuvant carboplatin in patients with triple-negative and HER2-positive early breast cancer (GeparSixto; GBG 66): a randomised phase 2 trial. Lancet Oncol. 2014 Jun;15(7):747-56. doi: 10.1016/S1470-2045(14)70160-3. Epub 2014 Apr 30.
PubMed 24794243
Chen XS, Yuan Y, Garfield DH, Wu JY, Huang O, Shen KW. Both carboplatin and bevacizumab improve pathological complete remission rate in neoadjuvant treatment of triple negative breast cancer: a meta-analysis. PLoS One. 2014 Sep 23;9(9):e108405. doi: 10.1371/journal.pone.0108405. eCollection 2014.
PubMed 25247558
Chen X, Huang J, Shi H, Zhu J, Wu W, Ye G, He Q, Shi Y, Zhang A, Xie X, Wang X, Chen X, Wu W, Wu J, Li Z, Li Z, Dai Y, Ren W, Shao Q, Chen Y, Zeng Y, Zhang F, Dong S, Pegram MD, Shen K. Adjuvant Epirubicin Plus Cyclophosphamide Followed by Taxanes With or Without Carboplatin in Early-Stage Triple-Negative Breast Cancer (RJBC 1501): A Randomized Phase III Trial. J Clin Oncol. 2026 Jan 20;44(3):143-152. doi: 10.1200/JCO-25-02412. Epub 2025 Dec 9.
PubMed 41365333

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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 locations

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All Breast Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Epirubicin-Cyclophosphamide Followed by Taxanes or Taxanes Plus Carboplatin in Triple-Negative Breast Cancer：A Prospective, Randomized, Phase III Trial
ClinicalTrials.gov ID: NCT02455141
Acronym / sponsor ID: TCTN / RJBC1501
Conditions: Breast Neoplasm
Keywords: chemptherapy, triple negative, taxanes, carboplatin
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 786 participants (actual)
Lead sponsor: Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Study start: Mar 2016 (actual)
Primary completion: Mar 2027 (estimated)
Study completion: Mar 2030 (estimated)
First posted: 27 May 2015 (estimated)
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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Taxanes	Active comparator	Drug: Epirubicin plus Cyclophosphamide, Drug: TaxanesEpirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel
Taxanes plus carboplatin	Experimental	Drug: Epirubicin plus Cyclophosphamide, Drug: Taxanes plus CarboplatinEpirubicin plus Cyclophosphamide followed by Paclitaxel or Docetaxel + Carboplatin

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Histologically confirmed adenocarcinoma of the breast, completely tumor removal by either modified radical mastectomy or local excision plus axillary lymph node dissection (i.e., breast conservation therapy) or sentinel node biopsy. (Tumor-free margins at least 1 mm for both invasive and noninvasive carcinoma except for lobular carcinoma in situ (less than 1 mm allowed);
Tumor specimens are available for estrogen receptor (ER), progesterone receptor (PgR) and Her2 (human epidermal-growth-factor receptor 2) detection, patients should be with triple negative breast cancer. Triple-negative disease is defined as ER <10% positivity, PgR <10% positivity, and negativity for Her2 (IHC (immunohistochemistry) 0-1+ or FISH (fluorescence in situ hybridization) negative);
Adequate bone marrow function
Adequate liver and renal function
Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1;

Key exclusion criteria (12 listed)

Prior systemic of breast cancer, including chemotherapy;
Metastatic breast cancer;
With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma;
Patients with medical conditions that indicate intolerant to adjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitus, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease;
Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive;

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
Epirubicin plus CyclophosphamideAlso: ECEpirubicin 90mg/m2, d1, q3w4 Cyclophosphamide: 600mg/m2, d1, q3w4	Drug	Taxanes, Taxanes plus carboplatin
TaxanesPaclitaxel: 80mg/m2, d1, qw12 or Docetaxel: 80-100mg/m2,d1,q3w4	Drug	Taxanes
Taxanes plus CarboplatinPaclitaxel: 80mg/m2, d1,d8,d15, q4w4 Carboplatin AUC=2, d1,d8,d15, q4w4 or Docetaxel: 75mg/m2,d1,q3w4 plus Carboplatin AUC=5-6, d1, q3w4	Drug	Taxanes plus carboplatin

Primary outcome

Disease-free survival
Time frame: From time of randomization to 5 years after enrollment.
The time from randomization to local or regional recurrence, distant metastases, other non-breast secondary primary malignancies, contralateral breast cancer, or death due to any cause, whichever occurs first.

3 secondary outcomes

Distant disease-free survival
Time frame: From time of randomization to 5 years after enrollment.
Overall Survival
Time frame: From time of randomization to 5 years after enrollment.
Incidence of adverse events
Time frame: From randomization to four weeks after end of study treatment

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 11 Jul 2025.
Background: PubMed 17928597Hayes DF, Thor AD, Dressler LG, Weaver D, Edgerton S, Cowan D, Broadwater G, Goldstein LJ, Martino S, Ingle JN, Henderson IC, Norton L, Winer EP, Hudis CA, Ellis MJ, Berry DA; Cancer and Leukemia Group B (CALGB) Investigators. HER2 and response to paclitaxel in node-positive breast cancer. N Engl J Med. 2007 Oct 11;357(15):1496-506. doi: 10.1056/NEJMoa071167.
Background: PubMed 20037779Martin M, Rodriguez-Lescure A, Ruiz A, Alba E, Calvo L, Ruiz-Borrego M, Santaballa A, Rodriguez CA, Crespo C, Abad M, Dominguez S, Florian J, Llorca C, Mendez M, Godes M, Cubedo R, Murias A, Batista N, Garcia MJ, Caballero R, de Alava E. Molecular predictors of efficacy of adjuvant weekly paclitaxel in early breast cancer. Breast Cancer Res Treat. 2010 Aug;123(1):149-57. doi: 10.1007/s10549-009-0663-z.
Background: PubMed 25092775Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance). J Clin Oncol. 2015 Jan 1;33(1):13-21. doi: 10.1200/JCO.2014.57.0572. Epub 2014 Aug 4.
Background: PubMed 24794243von Minckwitz G, Schneeweiss A, Loibl S, Salat C, Denkert C, Rezai M, Blohmer JU, Jackisch C, Paepke S, Gerber B, Zahm DM, Kummel S, Eidtmann H, Klare P, Huober J, Costa S, Tesch H, Hanusch C, Hilfrich J, Khandan F, Fasching PA, Sinn BV, Engels K, Mehta K, Nekljudova V, Untch M. Neoadjuvant carboplatin in patients with triple-negative and HER2-positive early breast cancer (GeparSixto; GBG 66): a randomised phase 2 trial. Lancet Oncol. 2014 Jun;15(7):747-56. doi: 10.1016/S1470-2045(14)70160-3. Epub 2014 Apr 30.
Background: PubMed 25247558Chen XS, Yuan Y, Garfield DH, Wu JY, Huang O, Shen KW. Both carboplatin and bevacizumab improve pathological complete remission rate in neoadjuvant treatment of triple negative breast cancer: a meta-analysis. PLoS One. 2014 Sep 23;9(9):e108405. doi: 10.1371/journal.pone.0108405. eCollection 2014.
Derived from this study: PubMed 41365333Chen X, Huang J, Shi H, Zhu J, Wu W, Ye G, He Q, Shi Y, Zhang A, Xie X, Wang X, Chen X, Wu W, Wu J, Li Z, Li Z, Dai Y, Ren W, Shao Q, Chen Y, Zeng Y, Zhang F, Dong S, Pegram MD, Shen K. Adjuvant Epirubicin Plus Cyclophosphamide Followed by Taxanes With or Without Carboplatin in Early-Stage Triple-Negative Breast Cancer (RJBC 1501): A Randomized Phase III Trial. J Clin Oncol. 2026 Jan 20;44(3):143-152. doi: 10.1200/JCO-25-02412. Epub 2025 Dec 9.

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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.

Kunwei Shen, professor principal investigator

Affiliated Ruijin Hospital of Shanghai JiaoTong University School of Medicine

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

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?

Disease-free survival (time frame: From time of randomization to 5 years after enrollment.). 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 NCT02455141, which also lists 6 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 11 Jul 2025.