Breast CancerPhase 2NCT01290718

A Study of Herceptin (Trastuzumab) in Combination With Xeloda (Capecitabine) in Patients With Metastatic or Recurrent HER2-positive Breast Cancer After First-Line or (Neo)Adjuvant Therapy.

A Phase 2 study testing capecitabine [Xeloda] and trastuzumab [Herceptin] in people with Breast Cancer, run by Hoffmann-La Roche at 6 sites in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: Breast Cancer
What is being tested?: capecitabine [Xeloda] and trastuzumab [Herceptin]
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 6 sitesTaiwan
Study dates: Dec 2011to Dec 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female patients, 18-65 years of age
Histologically confirmed HER2-positive breast cancer with measurable lesions (according to RECIST criteria)
Metastatic disease after first-line therapy or recurrent disease after (neo)adjuvant therapy with Herceptin and taxanes
ECOG performance status 0-2

Who cannot join

CNS metastases which are not well controlled
Simultaneous treatment with sorivudine
History of another malignancy within the last 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in-situ of the uterine cervix
Pregnant or lactating women

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Taiwan6 sites

Study site
Chai Yi, 613
Study site
Kaohsiung City, 807
Study site
Taipei, 00112
Study site
Taipei, 100
Study site
Taipei, 105
Study site
Taipei, 112

Other trials in Taiwan

About this study

Official title: Study of Trastuzumab Combined With Capecitabine on HER2-positive Metastatic Breast Cancer Patients Pretreated With Trastuzumab and Taxanes or HER2- Positive Breast Cancer Patients Relapsed From (Neo)Adjuvant Therapy of Trastuzumab and Taxanes

This single arm. open-label study will assess the efficacy and safety of Herceptin (trastuzumab) in combination with Xeloda (capecitabine) in patients with metastatic or recurrent HER2-positive breast cancer, refractory to or relapsing after chemotherapy with Herceptin and taxanes. Patients will receive Xeloda 900mg/m2 twice daily orally on days 1-14 of each 3-week cycle and Herceptin 8mg/kg intravenously (iv) on day 1 of the first cycle followed by 6mg/kg iv every 3 weeks. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Conditions: Breast Cancer
Being tested: capecitabine [Xeloda], trastuzumab [Herceptin]
Medical subject headings: Breast Neoplasms

What participants receive

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

capecitabine [Xeloda]Drug
900mg/m2 bid po on days 1-14 of each 3-week cycle
trastuzumab [Herceptin]Drug
8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg iv every 3 weeks

Study groups in NCT01290718
Study group	Role	What they receive
Single Arm	Experimental	Not described Receives: Drug: capecitabine [Xeloda]; Drug: trastuzumab [Herceptin]

What is being measured

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

Percentage of Participants With Overall Response
The tumor response was measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1).
Measured: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death

Secondary outcomes (3)

Time to Disease Progression
Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to progression is the time from the date of first dose of drug administration to the date when first disease progression is recorded.
Measured: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
Overall Survival
Overall survival (OS) is the time from the date of randomization to the date of death irrespective of the cause of death.
Measured: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
Progression-Free Survival
Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants without progression were censored at the date of last tumor assessment when non progression was documented.
Measured: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until 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.

Dec 2011Dec 2012

First posted7 Feb 2011 (estimated)
Study startDec 2011
Primary completionDec 2012
Study completionDec 2012

Why it stopped: Slow recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01290718
Sponsor's protocol ID: ML21833
Status last verified: Dec 2014
First submitted: 3 Feb 2011
Last updated: 17 Dec 2014
Results posted: Yes, on ClinicalTrials.gov

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

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Trastuzumab Combined With Capecitabine on HER2-positive Metastatic Breast Cancer Patients Pretreated With Trastuzumab and Taxanes or HER2- Positive Breast Cancer Patients Relapsed From (Neo)Adjuvant Therapy of Trastuzumab and Taxanes
ClinicalTrials.gov ID: NCT01290718
Acronym / sponsor ID: ML21833
Conditions: Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow recruitment
Enrolment: 4 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 7 Feb 2011 (estimated)
Results: Posted 17 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Arm	Experimental	Drug: capecitabine [Xeloda], Drug: trastuzumab [Herceptin]

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Female patients, 18-65 years of age
Histologically confirmed HER2-positive breast cancer with measurable lesions (according to RECIST criteria)
Metastatic disease after first-line therapy or recurrent disease after (neo)adjuvant therapy with Herceptin and taxanes
ECOG performance status 0-2

Key exclusion criteria (4 listed)

CNS metastases which are not well controlled
Simultaneous treatment with sorivudine
History of another malignancy within the last 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in-situ of the uterine cervix
Pregnant or lactating women

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
capecitabine [Xeloda]900mg/m2 bid po on days 1-14 of each 3-week cycle	Drug	Single Arm
trastuzumab [Herceptin]8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg iv every 3 weeks	Drug	Single Arm

Primary outcome

Percentage of Participants With Overall Response
Time frame: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
The tumor response was measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1).

3 secondary outcomes

Time to Disease Progression
Time frame: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
Overall Survival
Time frame: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
Progression-Free Survival
Time frame: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death

Results and safety

Results posted to the registry on 17 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Capecitabine Plus (+) Trastuzumab	4	0

Primary outcome: Percentage of Participants With Overall Response

Time frame: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death

Population analysed: Data were not analyzed due to early termination of the study.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) occurring up to 28 days after the last dose of study medication were to be reported.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Capecitabine + Trastuzumab	0 of 2 (0%)	0 of 2 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

Clinical Trials study director

Hoffmann-La Roche

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing capecitabine [Xeloda] and trastuzumab [Herceptin] in people with Breast Cancer, run by Hoffmann-La Roche at 6 sites in Taiwan.

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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Overall Response (time frame: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity 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 NCT01290718.

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 17 Dec 2014.