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AzTrials

Breast CancerPhase 3NCT01642771

Comparative Study on Two Post-operative Adjuvant Chemotherapy Regimens for Treating Triple-negative Breast Cancer

A Phase 3 study testing 5-Fu/epirubicin/CTX following Docetaxel and Docetaxel/capecitabine followed by XEC in people with Breast Cancer, run by China Breast Cancer Clinical Study Group at 37 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Recent clinical studies showed that triple-negative breast cancer patients (ER-/PR-/HER2-) may benefit more from Capecitabine chemotherapy. However, the optimum post-operative adjuvant Capecitabine chemotherapy regimen has not been determined for Chinese population with 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 Cancer
What is being tested?
5-Fu/epirubicin/CTX following Docetaxel and Docetaxel/capecitabine followed by XEC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
636 participants
Where
37 sitesChina
Study dates
Jun 2012to May 2020
Phase
Phase 3
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

  • Female aged 18 - 70 years old;
  • Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable);
  • Newly diagnosed conditions allowing direct surgery without any absolute contraindication for surgery;
  • No mass or microscopic tumor residue after surgery resection;
  • Initiate adjuvant chemotherapy within 30 days after surgery;
  • Axillary lymph node positive (including the sentinel lymph node positive and lymph node positive after axillary dissection), for example, axillary lymph node negative requires that primary tumor size must be greater than 1cm;
Show all 17Show fewer
  • Definite reports on ER/PR/Her2 receptor showing all ER/PR/Her2 negative (specific definitions: immunohistochemical detection of ER <10% tumor cells is defined as ER negative, PR <10% positive tumor cells is defined as PR-negative, Her2 is 0~1+ or 2+ but determined negative via FISH or CISH detected (no amplification) is defined as Her2 negative);
  • No relevant clinical or imaging evidence of metastasis showing in the preoperative examination (M0);
  • Without peripheral neuropathy;
  • ECOG performance score is 0 or 1;
  • Postoperative recovery was good and an interval of at least one week since the surgery is necessary;
  • White blood cell count> 4 × 10^9/l, neutrophil count> 2 × 10^9/l, platelet count> 100 × 10^9/l and hemoglobin 9g/dl);
  • ASAT and ALAT <1.5 folds of the upper limit of normal values, alkaline phosphatase <2.5 folds of the upper limit of normal values, total bilirubin <1.5 folds of the upper limit of normal values;
  • Serum creatinine <1.5 folds of the upper limit of normal value;
  • Women at childbearing age should take contraception measures during treatment;
  • Cardiac function: echocardiographic examination showed LEVF> 50%;
  • Informed consent form signed. -

Who cannot join

  • Bilateral breast cancer or carcinoma in situ (DCIS / LCIS);
  • Metastasis at any location;
  • Any tumor > T4a (UICC1987) (accompanied by skin involvement, lump adhesion and fixation, inflammatory breast cancer);
  • Any of ER, PR or Her-2 is positive;
  • Contralateral breast clinically or radiologically suspected to be malignant but not confirmed which needs a biopsy;
  • Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone therapy;
Show all 17Show fewer
  • Previously suffering from malignant tumors (except for basal cell carcinoma and cervical carcinoma in situ), including contralateral breast cancer;
  • Already enrolled into other clinical trials;
  • Severe systemic disease and/or uncontrollable infection, unable to be enrolled in this study
  • LEVF <50% (echocardiography);
  • Suffering from severe cardiovascular and cerebrovascular diseases within six months before the randomization (such as: unstable angina, chronic heart failure, uncontrollable high blood pressure > 150/90mmHg, myocardial infarction or brain vascular accident);
  • Known allergic to taxane and anthracycline agents;
  • Women at childbearing age refuse to take contraception measures during the treatment and 8 weeks after completion of treatment;
  • Pregnant and breast-feeding women;
  • Pregnancy test showed positive results before drug administration after enrolling in to the study;
  • With mental illness and cognitive impairment, unable to understand trial protocol and side effects and complete trial protocol and follow-ups (systematic evaluation is required before recruiting into this study);
  • Without personal freedom and independent civil capacity.

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

China37 sites

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Pekingn Union Medical College Hospital

    Beijing, Beijing Municipality, 100032

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • PLA 307 Hospital

    Beijing, Beijing Municipality, 100071

  • The General Hospital of the People's Liberation Army

    Beijing, Beijing Municipality, 100853

  • Jinlin Cancer Hospital & Institute

    Changchun, Jilin, 130012

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Xiangya Hospital Central-south University

    Changsha, Hunan, 410008

  • The First Affi liated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

  • South West Hospital

    Chongqing, Chongqing Municipality, 400038

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    Guangzhou, Guangdong, 510120

  • Second Affiliated Hospital of Zhongshan University

    Guangzhou, Guangdong, 510120

  • Affiliated Hospital of Guiyang Medical College

    Guiyang, Guizhou, 550002

  • Zhejiang First Hospital

    Hangzhou, Zhejiang, 310003

  • Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • The second affiliated hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • The third affiliated hospital of Harbin Medical University

    Harbin, Heilongjiang, 150040

  • Gansu Cancer Hospital

    Lanzhou, Gansu, 730050

  • Third Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330009

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shanghai 6th People's Hospital

    Shanghai, Shanghai Municipality, 200233

  • Changhai Hospital of Shanghai

    Shanghai, Shanghai Municipality, 200433

  • Cancer Hospital of Shantou Medical College

    Shantou, Guangdong, 515041

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • The Fourth Clinical Medical College of Hebei Medical University

    Shijiazhuang, Hebei, 050011

  • Jiangsu Cancer Hospital

    Suzhou, Jiangsu, 210000

  • Jiangsu Province Hospital

    Suzhou, Jiangsu, 210029

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030013

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Xinjiang Cancer Hospital

    Ürümqi, Xinjiang, 830000

  • The First Hospital of Wenzhou Medical College

    Wenzhou, Zhejiang, 325000

  • Hubei General Hospital

    Wuhan, Hubei, 430070

  • Second Affiliated Hospital of Medical College of Xi'An Jiaotong University

    Xi’an, Shanxi, 710004

  • Henan cancer hospital affiliated to Zhengzhou university

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: A Prospective, Randomized, Open, Multi-center Phase III Clinical Study Comparing Efficacy and Safety of Sequential T-FEC and TX-XEC as Post-operative Adjuvant Chemotherapy Options for the Treatment of Triple-negative Breast Cancer

Recent clinical studies showed that triple-negative breast cancer patients (ER-/PR-/HER2-) may benefit more from Capecitabine chemotherapy. However, the optimum post-operative adjuvant Capecitabine chemotherapy regimen has not been determined for Chinese population with triple-negative breast cancer. Thus it's necessary to conduct a multi-center Phase III clinical trial to verify efficacy and safety of Capecitabine in the treatment of triple-negative breast cancer. In this study, a prospective, randomized, open, multi-center Phase III clinical study was conducted to compare efficacy and safety of sequential Docetaxel followed by Fluorouracil/Epirubicin/Cyclophosphamide (FEC) and sequential Docetaxel and Capecitabine followed by Capecitabine/Epirubicin/Cyclophosphamide (XEC) as post-operative adjuvant chemotherapy in the treatment of triple-negative breast cancer in Chinese population.

Read the detailed description

Post-operative adjuvant chemotherapy has been shown to improve overall survival, delay local relapse and reduce distant metastasis by multiple large-scale prospective clinical trial. In registry clinical trial for Capecitabine conducted by O Shaughnessy, it revealed that a combined chemotherapy of Capecitabine and Docetaxel achieved better outcomes compared with Docetaxel alone. And the significant effect of Capecitabine was also evidenced by CHAT trial in which Trastuzumab/Docetaxel/Capecitabine regimen was proved to perform greater than Trastuzumab/Docetaxel regimen. In addition to better outcomes, Capecitabine also showed good tolerance and safety profile. In 2009, Finnish Breast Cancer Group published their study results from FinXX clinical trial on Lancet Oncology, and in this trial, they compared the efficacy between sequential Docetaxel (3 cycles) followed by 3 cycles of Fluorouracil/Epirubicin/Cyclophosphamide (FEC) and sequential Docetaxel and Capecitabine (3 cycles) followed by 3 cycles of Capecitabine/Epirubicin/Cyclophosphamide (XEC) in lymph positive or high-risk lymph negative early-stage breast cancer patients. And their results showed a better outcome in TX-XEC regimen. 5-year follow-up analysis of this trial revealed that combined Capecitabine regimen can bring more significant clinical benefits to triple-negative breast cancer patients. Another clinical trial NO1062 released their preliminary results on comparison of AC-T and AC-XT regimens and it showed that combined Capecitabine regimen can significantly improve overall survival and this effect is more obvious in triple--negative breast cancer patients.

Based on the results of FinXX and NO1062, it's of great value to optimize combined Capecitabine regimen and clarify involved questions, such as whether the efficacy of Capecitabine is related to its treatment course or not, whether Capecitabine should be combined into current standardized chemotherapy or a sequential therapy. Also, there are still no clear conclusions on the best post-operative adjuvant chemotherapy for triple--negative breast cancer patients. Especially in Chinese population, the efficacy and safety of Capecitabine in adjuvant chemotherapy has not been well established. So it's necessary to explore reasonable dosage, safety profile and efficacy of combined Capecitabine therapy. Based on this purpose, this study is hoped to compare efficacy and safety of sequential Docetaxel followed by Fluorouracil/Epirubicin/Cyclophosphamide (FEC) and sequential Docetaxel and Capecitabine followed by Capecitabine/Epirubicin/Cyclophosphamide (XEC) as post-operative adjuvant chemotherapy in the treatment of triple-negative breast cancer in Chinese population.

Conditions
Breast Cancer
Being tested
5-Fu/epirubicin/CTX following Docetaxel, Docetaxel/capecitabine followed by XEC
Keywords
Triple-negative Breast Cancer, Post-operative adjuvant Chemotherapy, Docetaxel, Capecitabine, Epirubicin, Cyclophosphamide, Fluorouracil
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

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

  • 5-Fu/epirubicin/CTX following DocetaxelDrug

    Also called Fluorouracil: 5-Fu

    Cycle 1-3: Docetaxel i.v. 75mg/m2 (One cycle = 21 days); Cycle 4-6: Fluorouracil i.v. 500 mg/m2, Epirubicin i.v. 75 mg/m2, Cyclophosphamide i.v. 500 mg/m2 (One cycle = 21 days)

  • Docetaxel/capecitabine followed by XECDrug

    Also called Capecitabine: Xeloda

    Cycle 1-3: Docetaxel i.v. 75 mg/m2, Capecitabine, p.o., 1000 mg/m2，b.i.d (take Capecitabine for 2 weeks and withdraw for 1 week) (One cycle = 21 days); Cycle 4-6: Capecitabine, i.v. 1000 mg/m2, b.i.d (take for 2 weeks and withdraw for 1 week),Epirubicin, i.v. 75 mg/m2, Cyclophosphamide, i.v. 500 mg/m2 (One cycle = 21 days)

Study groups in NCT01642771
Study groupRoleWhat they receive
5-Fu/epirubicin/CTX following DocetaxelActive comparatorDocetaxel for the first 3 cycles of chemotherapy followed by 3 cycles of FEC (Fluorouracil, epirubicin and cyclophosphamide) chemotherapy
Receives: Drug: 5-Fu/epirubicin/CTX following Docetaxel
Docetaxel/capecitabine followed by XECExperimentalDocetaxel/ capecitabine (TX) for the first 3 cycles of chemotherapy followed by 3 cycles of capecitabine/epirubicin/cyclophosphamide (XEC) chemotherapy
Receives: Drug: Docetaxel/capecitabine followed by XEC

What is being measured

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

  1. 5-year disease free survival

    Including local relapse, distant metastasis, contralateral breast cancer, second primary cancer or death from any cause

    Measured: 5 year after the completion of chemotherapy

Secondary outcomes (5)

  1. Number of Participants with Adverse Events as a Measure of Safety

    Safety will be evaluated based on adverse events observed and the number of participants with adverse events. Blood biological tests shall also be conducted for further examination.

    Measured: Within 5 years after the completion of chemotherapy

  2. FACT-B scale scores as a Measure of living quality

    FACT-B scale scores of participants would be assessed to reflect their living quality.

    Measured: Baseline, Week 0

  3. 5-year relapse free survival, distant disease free survival and overall survival as measures of efficacy

    Disease relapse shall be considered as the endpoint of relapse free survival and the period between surgery and disease relapse shall be recorded as a measure of efficacy.

    Also disease distant metastasis shall be considered as the endpoint of distant disease free survival and the period between surgery and Disease distant metastasis shall be recorded as a measure of efficacy.

    Measured: Within 5 years after the completion of chemotherapy

  4. FACT-B scale scores as a Measure of living quality

    FACT-B scale scores of participants would be assessed to reflect their living quality.

    Measured: Week 9

  5. FACT-B scale scores as a Measure of living quality

    FACT-B scale scores of participants would be assessed to reflect their living quality.

    Measured: Week 18

Timeline

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

  1. First posted17 Jul 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionDec 2019 (estimated)
  4. Study completionMay 2020 (estimated)

Resources

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
636 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01642771
Sponsor's protocol ID
EBC protocol 1.1
Status last verified
Apr 2017
First submitted
4 Jul 2012
Last updated
19 Apr 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Bria E, Nistico C, Cuppone F, Carlini P, Ciccarese M, Milella M, Natoli G, Terzoli E, Cognetti F, Giannarelli D. Benefit of taxanes as adjuvant chemotherapy for early breast cancer: pooled analysis of 15,500 patients. Cancer. 2006 Jun 1;106(11):2337-44. doi: 10.1002/cncr.21886.

    PubMed 16649217

  • Mamounas EP, Bryant J, Lembersky B, Fehrenbacher L, Sedlacek SM, Fisher B, Wickerham DL, Yothers G, Soran A, Wolmark N. Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28. J Clin Oncol. 2005 Jun 1;23(16):3686-96. doi: 10.1200/JCO.2005.10.517. Epub 2005 May 16.

    PubMed 15897552

  • Roche H, Fumoleau P, Spielmann M, Canon JL, Delozier T, Serin D, Symann M, Kerbrat P, Soulie P, Eichler F, Viens P, Monnier A, Vindevoghel A, Campone M, Goudier MJ, Bonneterre J, Ferrero JM, Martin AL, Geneve J, Asselain B. Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 Trial. J Clin Oncol. 2006 Dec 20;24(36):5664-71. doi: 10.1200/JCO.2006.07.3916. Epub 2006 Nov 20.

    PubMed 17116941

  • Piccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I, Gianni L, Baselga J, Bell R, Jackisch C, Cameron D, Dowsett M, Barrios CH, Steger G, Huang CS, Andersson M, Inbar M, Lichinitser M, Lang I, Nitz U, Iwata H, Thomssen C, Lohrisch C, Suter TM, Ruschoff J, Suto T, Greatorex V, Ward C, Straehle C, McFadden E, Dolci MS, Gelber RD; Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1659-72. doi: 10.1056/NEJMoa052306.

    PubMed 16236737

  • O'Shaughnessy J, Miles D, Vukelja S, Moiseyenko V, Ayoub JP, Cervantes G, Fumoleau P, Jones S, Lui WY, Mauriac L, Twelves C, Van Hazel G, Verma S, Leonard R. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol. 2002 Jun 15;20(12):2812-23. doi: 10.1200/JCO.2002.09.002.

    PubMed 12065558

  • Wardley AM, Pivot X, Morales-Vasquez F, Zetina LM, de Fatima Dias Gaui M, Reyes DO, Jassem J, Barton C, Button P, Hersberger V, Torres AA. Randomized phase II trial of first-line trastuzumab plus docetaxel and capecitabine compared with trastuzumab plus docetaxel in HER2-positive metastatic breast cancer. J Clin Oncol. 2010 Feb 20;28(6):976-83. doi: 10.1200/JCO.2008.21.6531. Epub 2009 Dec 28.

    PubMed 20038734

  • Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, Jukkola-Vuorinen A, Tanner M, Asola R, Kokko R, Ahlgren J, Auvinen P, Hemminki A, Paija O, Helle L, Nuortio L, Villman K, Nilsson G, Lahtela SL, Lehtio K, Pajunen M, Poikonen P, Nyandoto P, Kataja V, Bono P, Leinonen M, Lindman H; FinXX Study Investigators. Adjuvant capecitabine in combination with docetaxel and cyclophosphamide plus epirubicin for breast cancer: an open-label, randomised controlled trial. Lancet Oncol. 2009 Dec;10(12):1145-51. doi: 10.1016/S1470-2045(09)70307-9. Epub 2009 Nov 10.

    PubMed 19906561

  • Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

    PubMed 34037241

  • Li J, Yu K, Pang D, Wang C, Jiang J, Yang S, Liu Y, Fu P, Sheng Y, Zhang G, Cao Y, He Q, Cui S, Wang X, Ren G, Li X, Yu S, Liu P, Qu X, Tang J, Wang O, Fan Z, Jiang G, Zhang J, Wang J, Zhang H, Wang S, Zhang J, Jin F, Rao N, Ma B, He P, Xu B, Zhuang Z, Wang J, Sun Q, Guo X, Mo M, Shao Z; CBCSG010 Study Group. Adjuvant Capecitabine With Docetaxel and Cyclophosphamide Plus Epirubicin for Triple-Negative Breast Cancer (CBCSG010): An Open-Label, Randomized, Multicenter, Phase III Trial. J Clin Oncol. 2020 Jun 1;38(16):1774-1784. doi: 10.1200/JCO.19.02474. Epub 2020 Apr 10.

    PubMed 32275467

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 5-Fu/epirubicin/CTX following Docetaxel and Docetaxel/capecitabine followed by XEC in people with Breast Cancer, run by China Breast Cancer Clinical Study Group at 37 sites 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 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 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?

Results are not available in the source record.

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?

5-year disease free survival (time frame: 5 year after the completion of chemotherapy). 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 NCT01642771, which also lists 9 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 19 Apr 2017; AzTrials last refreshed its copy on 2 Nov 2026.

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