Carcinoma, Invasive Ductal, BreastPhase 3NCT01126138
Capecitabine (NX) Versus Docetaxel Plus Capecitabine (TX) as 1-line Chemotherapy on Metastatic Breast Cancer (MBC)
A Phase 3 study testing Vinorelbine plus Capecitabine for 6 cycles, followed by Capecitabine and Docetaxel plus Capecitabine for 6 cycles, followed by Capecitabine in people with Carcinoma, Invasive Ductal, Breast, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
It is a phase III trial to explore the efficacy and safety of vinorelbine plus capecitabine (NX) and docetaxel plus capecitabine (TX) as first line treatment followed by capecitabine alone till Progressive Disease(PD). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Carcinoma, Invasive Ductal, Breast
- What is being tested?
- Vinorelbine plus Capecitabine for 6 cycles, followed by Capecitabine and Docetaxel plus Capecitabine for 6 cycles, followed by Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to Aug 2015
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written and signed informed consent prior to beginning specific protocol procedures.
- Pathologically confirmed breast cancer and documented metastatic or locally advanced disease.
- Measurable disease (RECIST criteria) - with at least 1 lesion measurable by radiological method
- KPS>=70
- Adjuvant and/or Neoadjuvant chemotherapy, including an anthracycline was permitted
- Hormone therapy for early-stage or metastatic breast cancer was permitted if hormonal receptor positive.
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- Treatment with Herceptin for early-stage or metastatic breast cancer is permitted if HER2 positive
- Patients had to have concluded prior radiation therapy at least 14 days before enrollment.
- Laboratory requirements:
- Hematology Absolute neutrophil count>=1,500 /μl; Platelets>=100,000 /μl; Hemoglobin>=10 g/dl
- Liver function Total bilirubin<=2 times ULN ASAT (SGOT) and ALAT (SGPT)<=2.5 times UNL without liver metastasis or <=5.0 times if liver metastasis Glucose<=200 mg/dL
- Renal function Serum creatinine<=140 mol/l
- Life expectancy of at least 12 weeks
- Patients must be accessible for treatment and follow-up.
- Patients should have recovered from the acute reversible effects of prior treatment. This generally means at least 3 weeks should have elapsed since prior chemotherapy, adjuvant or Neoadjuvant treatment. and at least 4 weeks since prior (radical) radiotherapy or major surgery
Who cannot join
- Women who are pregnant or breast feeding
- History of brain and/or leptomeningeal metastases
- Previous chemotherapy for metastatic breast cancer
- Past or current history of malignant neoplasm other than breast carcinoma, except for curatively treated non melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
- Pre-existing neuropathy grade 1 according to the NCIC-CTC 3.0
- Psychiatric disorders or other conditions which would prevent pt. compliance
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- Other serious illness or medical condition:
- Congestive heart failure, or unstable angina pectoris, previous history of myocardial infarction within 6 month prior to study entry, uncontrolled hypertension as determined by the Investigator or high risk uncontrolled, arrhythmia.
- History of significant neurological or psychiatric disorders including psychotic disorders, dementia of seizures that would prohibit the understanding and giving of informed consent.
- Active uncontrolled infection.
- Unstable peptic ulcer, unstable diabetes mellitus or other contraindication for the use of Corticosteroids.
- Inability to take and/or absorb oral medicine
- Prior treatment with an docetaxel and/or capecitabine and/or vinorbine
- Concurrent treatment with other experimental drugs, or participation in another clinical trial with any investigational drug within 30 days prior to study entry
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Binghe Xu, MD, Ph.D, +86-10-87788826, xubinghe@medmail.com.cn
Jiayu Wang, MD, +86-13641238489, wangjiayu8778@sina.com
About this study
Official title: A Randomized Phase III Study to Investigate the Efficacy and Safety of Docetaxel + Capecitabine vs. Vinorelbine + Capecitabine Followed by Capecitabine Alone as 1st Therapy on Locally Advanced and Metastatic Breast Cancer Patients.
It is a phase III trial to explore the efficacy and safety of vinorelbine plus capecitabine (NX) and docetaxel plus capecitabine (TX) as first line treatment followed by capecitabine alone till Progressive Disease(PD). We plan to enroll 200 pts for limited budget and the non-inferior trend of the two curves is anticipated.
Read the detailed description
We designed the randomized non-inferiority study. Main Inclusion\& exclusion Criteria include: 1) Histologically or cytologically confirmed breast cancer with unresectable locally advanced and/or metastatic disease; 2) Untreated patients with unresectable locally advanced and/or metastatic disease; 3) with at least 1 lesion measurable by radiological method(RECIST criteria); 4) Karnofsky Performance Status(KPS)≥70; 5) normal Adequate hepatic, renal, and bone marrow function; 6) Life expectancy of at least 12 weeks; 7) No previous chemotherapy for metastatic breast cancer. Primary endpoint is Progression free survival(PFS), second endpoint are safety profiles (National Cancer Institute-Common Toxicity Criteria 3.0, NCI-CTC 3.0), overall survival and response rate. During Primary study treatment, Arm A: Capecitabine: 1,000 mg/m2 per ora(PO) twice daily (day 1-14), Vinorelbine 25 mg/m2 intravenous(IV) over 3 hours on day 1 and 8, every 3 weeks, 21 days as one cycle and 6-8 cycles are required; Arm B: Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14), Docetaxel 75 mg/m2 IV over 3 hours on day 1, every 3 weeks, 21 days as one cycle and 6-8 cycles are required. Patients who are responding (complete or partial), or whose disease is stable followed by Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14) 21 days as one cycle until progression or unacceptable toxicity
- Conditions
- Carcinoma, Invasive Ductal, Breast
- Being tested
- Vinorelbine plus Capecitabine for 6 cycles, followed by Capecitabine, Docetaxel plus Capecitabine for 6 cycles, followed by Capecitabine
- Keywords
- unresectable, locally advanced, metastatic, breast cancer
- Medical subject headings
- Carcinoma, Ductal, Breast, Neoplasm Metastasis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vinorelbine plus Capecitabine for 6 cycles, followed by CapecitabineDrug
Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14) Vinorelbine: 25 mg/m2 IV over 3 hours on day 1 and 8, every 3 weeks 21 days as one cycle and 6 cycles are required
Docetaxel plus Capecitabine for 6 cycles, followed by CapecitabineDrug
Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14), Docetaxel: 75 mg/m2 IV over 3 hours on day 1, every 3 weeks, 21 days as one cycle and 6 cycles are required.
Followed by Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14) 21 days as one cycle until progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Other | Vinorelbine plus Capecitabine Receives: Drug: Vinorelbine plus Capecitabine for 6 cycles, followed by Capecitabine |
| Arm B | Other | Docetaxel plus Capecitabine Receives: Drug: Docetaxel plus Capecitabine for 6 cycles, followed by Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival(PFS)
Progress free survival is defined as the time from first dose of test drug to the first recording of disease progression or the date of death in patients with no evidence of disease progression.
In addition to hazard ratios and associated 95% confidence intervals, the results from these analyses will, for each treatment arm, also be summarized by Kaplan-Meier plots, medians and 95% confidence intervals.
Measured: Up to 2 years until disease progression or death
Secondary outcomes (3)
Safety Profiles
All adverse events occurring up to 28 days after last intake of study medication are to be recorded in the case report form. Safety profile will be analyzed by tabulating its occurring frequency and percentage per patient using NCI-CTC version 3.0. χ2 statistics will be used to test the differences in toxicities between the two treatment arms.
SAEs will be reported according to ICH-GCP.
Measured: Up to 2 years until 28 days after last intake of study medication
Overall Survival
Survival will be measured from the date of first dose of test drug to the date of death (any cause) or to the date of last contact.
Measured: Up to 3 years after last intake of study medication
Response Rate
Tumor responses were assessed on the basis of Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at 6-week intervals then at 12-week intervals after disease progression.
Measured: Up to 2 years until disease progression, unacceptable toxicity or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Invasive Ductal, BreastStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Binghe Xu, MD, Ph.D, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126138
- Sponsor's protocol ID
- ML25241
- Status last verified
- May 2010
- First submitted
- 18 May 2010
- Last updated
- 4 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Sjostrom J, Blomqvist C, Mouridsen H, Pluzanska A, Ottosson-Lonn S, Bengtsson NO, Ostenstad B, Mjaaland I, Palm-Sjovall M, Wist E, Valvere V, Anderson H, Bergh J. Docetaxel compared with sequential methotrexate and 5-fluorouracil in patients with advanced breast cancer after anthracycline failure: a randomised phase III study with crossover on progression by the Scandinavian Breast Group. Eur J Cancer. 1999 Aug;35(8):1194-201. doi: 10.1016/s0959-8049(99)00122-7.
PubMed 10615229Ghosn M, Kattan J, Farhat F, Younes F, Gasmi J. Phase II trial of capecitabine and vinorelbine as first-line chemotherapy for metastatic breast cancer patients. Anticancer Res. 2006 May-Jun;26(3B):2451-6.
PubMed 16821631Welt A, von Minckwitz G, Oberhoff C, Borquez D, Schleucher R, Loibl S, Harstrick A, Kaufmann M, Seeber S, Vanhoefer U. Phase I/II study of capecitabine and vinorelbine in pretreated patients with metastatic breast cancer. Ann Oncol. 2005 Jan;16(1):64-9. doi: 10.1093/annonc/mdi024.
PubMed 15598940Chan A, Verrill M. Capecitabine and vinorelbine in metastatic breast cancer. Eur J Cancer. 2009 Sep;45(13):2253-65. doi: 10.1016/j.ejca.2009.04.031. Epub 2009 May 20.
PubMed 19464166O'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
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study to Investigate the Efficacy and Safety of Docetaxel + Capecitabine vs. Vinorelbine + Capecitabine Followed by Capecitabine Alone as 1st Therapy on Locally Advanced and Metastatic Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT01126138
- Acronym / sponsor ID
- ML25241
- Conditions
- Carcinoma, Invasive Ductal, Breast
- Keywords
- unresectable, locally advanced, metastatic, breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Jul 2010
- Primary completion
- May 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 19 May 2010 (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.
It is a phase III trial to explore the efficacy and safety of vinorelbine plus capecitabine (NX) and docetaxel plus capecitabine (TX) as first line treatment followed by capecitabine alone till Progressive Disease(PD). We plan to enroll 200 pts for limited budget and the non-inferior trend of the two curves is anticipated.
Detailed description
We designed the randomized non-inferiority study. Main Inclusion\& exclusion Criteria include: 1) Histologically or cytologically confirmed breast cancer with unresectable locally advanced and/or metastatic disease; 2) Untreated patients with unresectable locally advanced and/or metastatic disease; 3) with at least 1 lesion measurable by radiological method(RECIST criteria); 4) Karnofsky Performance Status(KPS)≥70; 5) normal Adequate hepatic, renal, and bone marrow function; 6) Life expectancy of at least 12 weeks; 7) No previous chemotherapy for metastatic breast cancer. Primary endpoint is Progression free survival(PFS), second endpoint are safety profiles (National Cancer Institute-Common Toxicity Criteria 3.0, NCI-CTC 3.0), overall survival and response rate. During Primary study treatment, Arm A: Capecitabine: 1,000 mg/m2 per ora(PO) twice daily (day 1-14), Vinorelbine 25 mg/m2 intravenous(IV) over 3 hours on day 1 and 8, every 3 weeks, 21 days as one cycle and 6-8 cycles are required; Arm B: Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14), Docetaxel 75 mg/m2 IV over 3 hours on day 1, every 3 weeks, 21 days as one cycle and 6-8 cycles are required. Patients who are responding (complete or partial), or whose disease is stable followed by Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14) 21 days as one cycle until progression or unacceptable toxicity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Other | Drug: Vinorelbine plus Capecitabine for 6 cycles, followed by CapecitabineVinorelbine plus Capecitabine |
| Arm B | Other | Drug: Docetaxel plus Capecitabine for 6 cycles, followed by CapecitabineDocetaxel plus Capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written and signed informed consent prior to beginning specific protocol procedures.
- Pathologically confirmed breast cancer and documented metastatic or locally advanced disease.
- Measurable disease (RECIST criteria) - with at least 1 lesion measurable by radiological method
- KPS>=70
- Adjuvant and/or Neoadjuvant chemotherapy, including an anthracycline was permitted
Key exclusion criteria (14 listed)
- Women who are pregnant or breast feeding
- History of brain and/or leptomeningeal metastases
- Previous chemotherapy for metastatic breast cancer
- Past or current history of malignant neoplasm other than breast carcinoma, except for curatively treated non melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
- Pre-existing neuropathy grade 1 according to the NCIC-CTC 3.0
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 |
|---|---|---|
| Vinorelbine plus Capecitabine for 6 cycles, followed by CapecitabineCapecitabine: 1,000 mg/m2 PO twice daily (day 1-14) Vinorelbine: 25 mg/m2 IV over 3 hours on day 1 and 8, every 3 weeks 21 days as one cycle and 6 cycles are required | Drug | Arm A |
| Docetaxel plus Capecitabine for 6 cycles, followed by CapecitabineCapecitabine: 1,000 mg/m2 PO twice daily (day 1-14), Docetaxel: 75 mg/m2 IV over 3 hours on day 1, every 3 weeks, 21 days as one cycle and 6 cycles are required. Followed by Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14) 21 days as one cycle until progression or unacceptable toxicity | Drug | Arm B |
Primary outcome
Progression free survival(PFS)
Time frame: Up to 2 years until disease progression or death
Progress free survival is defined as the time from first dose of test drug to the first recording of disease progression or the date of death in patients with no evidence of disease progression. In addition to hazard ratios and associated 95% confidence intervals, the results from these analyses will, for each treatment arm, also be summarized by Kaplan-Meier plots, medians and 95% confidence intervals.
3 secondary outcomes
Safety Profiles
Time frame: Up to 2 years until 28 days after last intake of study medication
Overall Survival
Time frame: Up to 3 years after last intake of study medication
Response Rate
Time frame: Up to 2 years until disease progression, unacceptable toxicity or death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2011.
- Background: PubMed 10615229Sjostrom J, Blomqvist C, Mouridsen H, Pluzanska A, Ottosson-Lonn S, Bengtsson NO, Ostenstad B, Mjaaland I, Palm-Sjovall M, Wist E, Valvere V, Anderson H, Bergh J. Docetaxel compared with sequential methotrexate and 5-fluorouracil in patients with advanced breast cancer after anthracycline failure: a randomised phase III study with crossover on progression by the Scandinavian Breast Group. Eur J Cancer. 1999 Aug;35(8):1194-201. doi: 10.1016/s0959-8049(99)00122-7.
- Background: PubMed 16821631Ghosn M, Kattan J, Farhat F, Younes F, Gasmi J. Phase II trial of capecitabine and vinorelbine as first-line chemotherapy for metastatic breast cancer patients. Anticancer Res. 2006 May-Jun;26(3B):2451-6.
- Background: PubMed 15598940Welt A, von Minckwitz G, Oberhoff C, Borquez D, Schleucher R, Loibl S, Harstrick A, Kaufmann M, Seeber S, Vanhoefer U. Phase I/II study of capecitabine and vinorelbine in pretreated patients with metastatic breast cancer. Ann Oncol. 2005 Jan;16(1):64-9. doi: 10.1093/annonc/mdi024.
- Background: PubMed 19464166Chan A, Verrill M. Capecitabine and vinorelbine in metastatic breast cancer. Eur J Cancer. 2009 Sep;45(13):2253-65. doi: 10.1016/j.ejca.2009.04.031. Epub 2009 May 20.
- Results publication: PubMed 12065558O'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.
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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.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
Binghe Xu, MD, Ph.D principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Vinorelbine plus Capecitabine for 6 cycles, followed by Capecitabine and Docetaxel plus Capecitabine for 6 cycles, followed by Capecitabine in people with Carcinoma, Invasive Ductal, Breast, run by Chinese Academy of Medical Sciences 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 15 inclusion and 14 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 4 May 2011. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival(PFS) (time frame: Up to 2 years until disease progression or death). 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 NCT01126138, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2011.