Breast Neoplasm FemalePhase 3NACVCACNCT03011060
Sequential Neo-adjuvant Chemotherapy Followed by Capecitabine Vs. Conventional Adjuvant Chemotherapy in Breast Cancer
A Phase 3 study testing Neo-adjuvant Chemotherapy and Capecitabine in people with Breast Neoplasm Female, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
This study evaluates whether sequential neo-adjuvant chemotherapy plus surgery followed by Capecitabine could achieve additional benefits over traditional postoperative chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- Neo-adjuvant Chemotherapy and Capecitabine
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,588 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Feb 2025
- 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
- Pathologically confirmed unilateral invasive carcinoma (all pathological types);
- No gross or microscopic residual tumor after resection;
- Clinical stage Ⅰ-stage Ⅲ A, no absolute surgical contraindications;
- Eastern Cooperative Oncology Group(ECOG) score ≤1;
- Accepting adjuvant chemotherapy within 15 days after surgery;
- No peripheral neuropathy;
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- Normal bone marrow and organ functions:
- Bone marrow function: ANC≥1500/mm3，PLT≥100000/mm3，HGB≥8g/dl
- Renal function: serum creatinine≤1.5 times the upper limit of normal(ULN), Liver function: total bilirubin ≤1.5 times the upper limit of normal，AST≤2.5 times the upper limit of normal，alanine aminotransferase(ALT)≤2.5 times the upper limit of normal
- Cardiac function:LVEF≥50%
- Signed informed consent form.
Who cannot join
- Patients with the history of oral fluorouracil chemotherapy or Chinese medicine treatment;
- Patients with organ dysfunction:
- Renal function: serum creatinine>1.5 times the upper limit of normal
- Liver function: total bilirubin>1.5 times the upper limit of normal，AST>1.5 times the upper limit of normal, alanine aminotransferase(ALT)>1.5 times the upper limit of normal or alkaline phosphatase (ALP) >2.5 times the upper limit of normal
- Cardiac function：LVEF<50%;
- Human epidermal growth factor receptor-2(HER-2) positive patients who cannot receive Herceptin treatment with a left ventricular ejection fraction(LVEF) less than 55%;
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- Patients allergic to docetaxel, capecitabine, epirubicin and cyclophosphamide;
- Patients with severe systemic disease and/or uncontrollable infections;
- Patients with previous malignancies, including contralateral breast cancer;
- Patients with severe cardiovascular and cerebrovascular disease(i.e. Unstable angina, chronic cardiac failure, uncontrollable high blood pressure of >150/90 mmhg, myocardial infarction and cerebrovascular accident) history within 6 months before randomization;
- Pregnant or lactating women.
- Patients who have cognitive or psychological impairment as well as cannot understand the test program or stand side effects, which will result in a suspension of the trial program and follow-up;
- Patients without personal freedom or independent civil capacity.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Hospital of Jilin University
Changchun, Jilin, 130000
Fan Zhimin, Professor, +86 13756661286, fanzhimn@163.com
Han Bing, Professor, +86 13504316519, han_bing@jlu.edu.cn
About this study
Official title: A Prospective Randomized Controlled Trail to Evaluate Efficacy and Safety of Sequential Neo-adjuvant Chemotherapy Plus Surgery Followed by Capecitabine Versus Conventional Postoperative Adjuvant Chemotherapy
This study evaluates whether sequential neo-adjuvant chemotherapy plus surgery followed by Capecitabine could achieve additional benefits over traditional postoperative chemotherapy. In the study group, patients that do not achieve pathological complete response(pCR) will receive sequential neo-adjuvant chemotherapy followed by Capecitabine. In the control group, patients will be treated with postoperative adjuvant chemotherapy.
Read the detailed description
Neo-adjuvant chemotherapy(NAC) is a standard treatment for locally advanced breast cancer(LABC). By down-staging LABC, NAC is able to make inoperable cases operable as well as to make breast conserving surgery an option again for some patients.Neo-adjuvant chemotherapy is more and more widely used in operable breast cancer since it provides critical information on chemotherapy response. However, only 15% to 20% of the patients can benefit from Neo-adjuvant chemotherapy and achieve pCR. Although we obtained the information chemotherapy response for the rest of the patients who received Neo-adjuvant chemotherapy, there are still controversies on how the information will be used for further treatment. Therefore, it is a problem that needs resolving how these patients can benefit from the information Neo-adjuvant chemotherapy provides and whether Neo-adjuvant chemotherapy can replace conventional adjuvant chemotherapy at all. Our study aims to make Neo-adjuvant chemotherapy benefit more patients.
Registered patients in stage Ⅰ- Ⅲ A breast cancer is randomly split into two groups(study group and control group).In the study group, patients achieving pCR will be followed up for 5 years while patients that do not achieve pCR after neo-adjuvant chemotherapy will be treated with Capecitabine for 8 cycles after surgery. On the other hand, patients in the control group will accept surgeries and conventional adjuvant chemotherapies. Follow-up study will last 5 years. DFS and OS will be compared between the two groups.
This study provides an important basis and methods for the further treatment of patients after neo-adjuvant chemotherapy. It discusses whether neo-adjuvant chemotherapy could replace conventional adjuvant chemotherapy and become a new standard for breast cancer treatment.
- Conditions
- Breast Neoplasm Female
- Being tested
- Neo-adjuvant Chemotherapy, Capecitabine
- Keywords
- neo-adjuvant chemotherapy, pathological complete response, Neoadjuvant Therapy, Capecitabine, Chemotherapy, Adjuvant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neo-adjuvant ChemotherapyProcedure or surgery
Also called Preoperative Chemotherapy, Primary Chemotherapy, Induction Chemotherapy
A preoperative chemotherapy based on anthracyclines and taxanes.
CapecitabineDrug
Also called Xeloda
Capecitabine 1000mg/m2 tablets twice a day for 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| NAC not achieving pCR | Experimental | Patients in the study group will accept neo-adjuvant chemotherapy. Among these patients, those who do not achieve pCR after neo-adjuvant chemotherapy will be treated with Capecitabine after surgery. And then they will be followed up for 5 years.
Capecitabine 1000mg/m2 tablets twice a day for 8 cycles. Receives: Procedure: Neo-adjuvant Chemotherapy; Drug: Capecitabine |
| NAC achieving pCR | Experimental | Patients in the study group will accept neo-adjuvant chemotherapy. In these patients, those who reach to pCR after neo-adjuvant chemotherapy will be followed up for 5 years after surgery. Receives: Procedure: Neo-adjuvant Chemotherapy |
| Adjuvant Chemotherapy | No intervention | Patients in the control group will accept surgeries and corresponding adjuvant chemotherapy.They will be followed up for 5 years after adjuvant chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival(DFS)
Measured: 5 years
Secondary outcomes (1)
Overall survival(OS)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe 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
- 1,588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospital of China Medical University, The Second Affiliated Hospital of Harbin Medical University, Qingdao University, First Affiliated Hospital Xi'an Jiaotong University, Baotou Cancer Hospital
- Responsible party
- Sponsor
- Investigators
- Fan Zhimin, Professor, Study chair, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011060
- Sponsor's protocol ID
- JLUDBSCRH 001
- Acronym
- NACVCAC
- Status last verified
- Jan 2017
- First submitted
- 3 Jan 2017
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Fisher B, Brown A, Mamounas E, Wieand S, Robidoux A, Margolese RG, Cruz AB Jr, Fisher ER, Wickerham DL, Wolmark N, DeCillis A, Hoehn JL, Lees AW, Dimitrov NV. Effect of preoperative chemotherapy on local-regional disease in women with operable breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-18. J Clin Oncol. 1997 Jul;15(7):2483-93. doi: 10.1200/JCO.1997.15.7.2483.
PubMed 9215816Bear HD, Anderson S, Smith RE, Geyer CE Jr, Mamounas EP, Fisher B, Brown AM, Robidoux A, Margolese R, Kahlenberg MS, Paik S, Soran A, Wickerham DL, Wolmark N. Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer:National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2006 May 1;24(13):2019-27. doi: 10.1200/JCO.2005.04.1665. Epub 2006 Apr 10.
PubMed 16606972Specht J, Gralow JR. Neoadjuvant chemotherapy for locally advanced breast cancer. Semin Radiat Oncol. 2009 Oct;19(4):222-8. doi: 10.1016/j.semradonc.2009.05.001.
PubMed 19732686Mathew J, Asgeirsson KS, Cheung KL, Chan S, Dahda A, Robertson JF. Neoadjuvant chemotherapy for locally advanced breast cancer: a review of the literature and future directions. Eur J Surg Oncol. 2009 Feb;35(2):113-22. doi: 10.1016/j.ejso.2008.03.015. Epub 2008 May 23.
PubMed 18502088Mieog JS, van de Velde CJ. Neoadjuvant chemotherapy for early breast cancer. Expert Opin Pharmacother. 2009 Jun;10(9):1423-34. doi: 10.1517/14656560903002105.
PubMed 19505212Alliot C. In vivo chemosensitivity-adapted preoperative chemotherapy in patients with early-stage breast cancer. Ann Oncol. 2005 Sep;16(9):1559-60; author reply 1560-1. doi: 10.1093/annonc/mdi287. Epub 2005 Aug 3. No abstract available.
PubMed 16079161Joensuu 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 19906561M Toi, S-J Lee.Abstract S1-07: A phase III trial of adjuvant capecitabine in breast cancer patients with HER2-negative pathologic residual invasive disease after neoadjuvant chemotherapy (CREATE-X, JBCRG-04). American Association for Cancer Research 76(4 Supplement):S1-07,2016
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trail to Evaluate Efficacy and Safety of Sequential Neo-adjuvant Chemotherapy Plus Surgery Followed by Capecitabine Versus Conventional Postoperative Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT03011060
- Acronym / sponsor ID
- NACVCAC / JLUDBSCRH 001
- Conditions
- Breast Neoplasm Female
- Keywords
- neo-adjuvant chemotherapy, pathological complete response, Neoadjuvant Therapy, Capecitabine, Chemotherapy, Adjuvant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,588 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Collaborators
- First Hospital of China Medical University, The Second Affiliated Hospital of Harbin Medical University, Qingdao University, First Affiliated Hospital Xi'an Jiaotong University, Baotou Cancer Hospital
- Study start
- Dec 2016
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 5 Jan 2017 (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.
This study evaluates whether sequential neo-adjuvant chemotherapy plus surgery followed by Capecitabine could achieve additional benefits over traditional postoperative chemotherapy. In the study group, patients that do not achieve pathological complete response(pCR) will receive sequential neo-adjuvant chemotherapy followed by Capecitabine. In the control group, patients will be treated with postoperative adjuvant chemotherapy.
Detailed description
Neo-adjuvant chemotherapy(NAC) is a standard treatment for locally advanced breast cancer(LABC). By down-staging LABC, NAC is able to make inoperable cases operable as well as to make breast conserving surgery an option again for some patients.Neo-adjuvant chemotherapy is more and more widely used in operable breast cancer since it provides critical information on chemotherapy response. However, only 15% to 20% of the patients can benefit from Neo-adjuvant chemotherapy and achieve pCR. Although we obtained the information chemotherapy response for the rest of the patients who received Neo-adjuvant chemotherapy, there are still controversies on how the information will be used for further treatment. Therefore, it is a problem that needs resolving how these patients can benefit from the information Neo-adjuvant chemotherapy provides and whether Neo-adjuvant chemotherapy can replace conventional adjuvant chemotherapy at all. Our study aims to make Neo-adjuvant chemotherapy benefit more patients.
Registered patients in stage Ⅰ- Ⅲ A breast cancer is randomly split into two groups(study group and control group).In the study group, patients achieving pCR will be followed up for 5 years while patients that do not achieve pCR after neo-adjuvant chemotherapy will be treated with Capecitabine for 8 cycles after surgery. On the other hand, patients in the control group will accept surgeries and conventional adjuvant chemotherapies. Follow-up study will last 5 years. DFS and OS will be compared between the two groups.
This study provides an important basis and methods for the further treatment of patients after neo-adjuvant chemotherapy. It discusses whether neo-adjuvant chemotherapy could replace conventional adjuvant chemotherapy and become a new standard for breast cancer treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NAC not achieving pCR | Experimental | Procedure: Neo-adjuvant Chemotherapy, Drug: CapecitabinePatients in the study group will accept neo-adjuvant chemotherapy. Among these patients, those who do not achieve pCR after neo-adjuvant chemotherapy will be treated with Capecitabine after surgery. And then they will be followed up for 5 years. Capecitabine 1000mg/m2 tablets twice a day for 8 cycles. |
| NAC achieving pCR | Experimental | Procedure: Neo-adjuvant ChemotherapyPatients in the study group will accept neo-adjuvant chemotherapy. In these patients, those who reach to pCR after neo-adjuvant chemotherapy will be followed up for 5 years after surgery. |
| Adjuvant Chemotherapy | No intervention | –Patients in the control group will accept surgeries and corresponding adjuvant chemotherapy.They will be followed up for 5 years after adjuvant chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pathologically confirmed unilateral invasive carcinoma (all pathological types);
- No gross or microscopic residual tumor after resection;
- Clinical stage Ⅰ-stage Ⅲ A, no absolute surgical contraindications;
- Eastern Cooperative Oncology Group(ECOG) score ≤1;
- Accepting adjuvant chemotherapy within 15 days after surgery;
Key exclusion criteria (13 listed)
- Patients with the history of oral fluorouracil chemotherapy or Chinese medicine treatment;
- Patients with organ dysfunction:
- Human epidermal growth factor receptor-2(HER-2) positive patients who cannot receive Herceptin treatment with a left ventricular ejection fraction(LVEF) less than 55%;
- Patients allergic to docetaxel, capecitabine, epirubicin and cyclophosphamide;
- Patients with severe systemic disease and/or uncontrollable infections;
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 |
|---|---|---|
| Neo-adjuvant ChemotherapyAlso: Preoperative Chemotherapy, Primary Chemotherapy, Induction ChemotherapyA preoperative chemotherapy based on anthracyclines and taxanes. | Procedure or surgery | NAC achieving pCR, NAC not achieving pCR |
| CapecitabineAlso: XelodaCapecitabine 1000mg/m2 tablets twice a day for 8 cycles. | Drug | NAC not achieving pCR |
Primary outcome
Disease-free survival(DFS)
Time frame: 5 years
1 secondary outcome
Overall survival(OS)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Results publication: PubMed 9215816Fisher B, Brown A, Mamounas E, Wieand S, Robidoux A, Margolese RG, Cruz AB Jr, Fisher ER, Wickerham DL, Wolmark N, DeCillis A, Hoehn JL, Lees AW, Dimitrov NV. Effect of preoperative chemotherapy on local-regional disease in women with operable breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-18. J Clin Oncol. 1997 Jul;15(7):2483-93. doi: 10.1200/JCO.1997.15.7.2483.
- Results publication: PubMed 16606972Bear HD, Anderson S, Smith RE, Geyer CE Jr, Mamounas EP, Fisher B, Brown AM, Robidoux A, Margolese R, Kahlenberg MS, Paik S, Soran A, Wickerham DL, Wolmark N. Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer:National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2006 May 1;24(13):2019-27. doi: 10.1200/JCO.2005.04.1665. Epub 2006 Apr 10.
- Results publication: PubMed 19732686Specht J, Gralow JR. Neoadjuvant chemotherapy for locally advanced breast cancer. Semin Radiat Oncol. 2009 Oct;19(4):222-8. doi: 10.1016/j.semradonc.2009.05.001.
- Results publication: PubMed 18502088Mathew J, Asgeirsson KS, Cheung KL, Chan S, Dahda A, Robertson JF. Neoadjuvant chemotherapy for locally advanced breast cancer: a review of the literature and future directions. Eur J Surg Oncol. 2009 Feb;35(2):113-22. doi: 10.1016/j.ejso.2008.03.015. Epub 2008 May 23.
- Results publication: PubMed 19505212Mieog JS, van de Velde CJ. Neoadjuvant chemotherapy for early breast cancer. Expert Opin Pharmacother. 2009 Jun;10(9):1423-34. doi: 10.1517/14656560903002105.
- Results publication: PubMed 16079161Alliot C. In vivo chemosensitivity-adapted preoperative chemotherapy in patients with early-stage breast cancer. Ann Oncol. 2005 Sep;16(9):1559-60; author reply 1560-1. doi: 10.1093/annonc/mdi287. Epub 2005 Aug 3. No abstract available.
- Results publication: PubMed 19906561Joensuu 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.
- Results publicationM Toi, S-J Lee.Abstract S1-07: A phase III trial of adjuvant capecitabine in breast cancer patients with HER2-negative pathologic residual invasive disease after neoadjuvant chemotherapy (CREATE-X, JBCRG-04). American Association for Cancer Research 76(4 Supplement):S1-07,2016
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fan Zhimin, Professor study chair
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neo-adjuvant Chemotherapy and Capecitabine in people with Breast Neoplasm Female, run by The First Hospital of Jilin University 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 11 inclusion and 13 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 10 Jan 2017. 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 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?
Contact Fan Zhimin, Professor (+8613756661286, fanzhimn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival(DFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03011060, which also lists 8 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 10 Jan 2017.