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Capecitabine (NX) Versus Docetaxel Plus Capecitabine (TX) as 1-line Chemotherapy on Metastatic Breast Cancer (MBC)

Primary Purpose

Carcinoma, Invasive Ductal, Breast

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Vinorelbine plus Capecitabine for 6 cycles, followed by Capecitabine

Docetaxel plus Capecitabine for 6 cycles, followed by Capecitabine

About this trial

This is an interventional treatment trial for Carcinoma, Invasive Ductal, Breast focused on measuring unresectable, locally advanced, metastatic, breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.
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

Exclusion Criteria:

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
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

Sites / Locations

Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Arm A

Arm B

Arm Description

Vinorelbine plus Capecitabine

Docetaxel plus Capecitabine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT01126138

First Posted

May 18, 2010

Last Updated

May 3, 2011

Sponsor

Chinese Academy of Medical Sciences

Collaborators

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01126138

Brief Title

Capecitabine (NX) Versus Docetaxel Plus Capecitabine (TX) as 1-line Chemotherapy on Metastatic Breast Cancer (MBC)

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Unknown status

Study Start Date

July 2010 (undefined)

Primary Completion Date

May 2015 (Anticipated)

Study Completion Date

August 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Chinese Academy of Medical Sciences

Collaborators

Hoffmann-La Roche

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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). 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Invasive Ductal, Breast

Keywords

unresectable, locally advanced, metastatic, breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Other

Arm Description

Vinorelbine plus Capecitabine

Arm Title

Arm B

Arm Type

Other

Arm Description

Docetaxel plus Capecitabine

Intervention Type

Drug

Intervention Name(s)

Vinorelbine plus Capecitabine for 6 cycles, followed by Capecitabine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Docetaxel plus Capecitabine for 6 cycles, followed by Capecitabine

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression free survival(PFS)

Description

Time Frame

Up to 2 years until disease progression or death

Secondary Outcome Measure Information:

Title

Safety Profiles

Description

Time Frame

Up to 2 years until 28 days after last intake of study medication

Title

Overall Survival

Description

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.

Time Frame

Up to 3 years after last intake of study medication

Title

Response Rate

Description

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.

Time Frame

Up to 2 years until disease progression, unacceptable toxicity or death

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Binghe Xu, MD, Ph.D

Organizational Affiliation

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

City

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Binghe Xu, MD, Ph.D

Phone

+86-10-87788826

xubinghe@medmail.com.cn

First Name & Middle Initial & Last Name & Degree

Jiayu Wang, MD

Phone

+86-13641238489

wangjiayu8778@sina.com

First Name & Middle Initial & Last Name & Degree

Binghe Xu, MD, Ph.D

First Name & Middle Initial & Last Name & Degree

Jiayu Wang, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

10615229

Citation

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.

Results Reference

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PubMed Identifier

16821631

Citation

Ghosn 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.

Results Reference

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PubMed Identifier

15598940

Citation

Welt 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.

Results Reference

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PubMed Identifier

19464166

Citation

Chan 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 Reference

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PubMed Identifier

12065558

Citation

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.

Results Reference

result

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Capecitabine (NX) Versus Docetaxel Plus Capecitabine (TX) as 1-line Chemotherapy on Metastatic Breast Cancer (MBC)

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