Breast CancerPhase 1/2NCT00337649

A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer

A Phase 1/2 study testing Epothilone D and Herceptin in people with Breast Cancer, run by Hoffmann-La Roche at 6 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: Epothilone D and Herceptin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 6 sitesSpain
Study dates: May 2004to Jul 2007
Phase: Phase 1/2
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

women >=18 years;
locally advanced or metastatic breast cancer;
HER-2 overexpression (FISH + or IHC 3+);
>=1 measurable lesion;
up to one prior anthracycline-based chemotherapy regimen in a metastatic setting.

Who cannot join

pre-existing neuropathy >=grade 2;
known CNS metastases;
congestive heart failure, or myocardial infarction within the last 6 months;
previous malignancies in last 5 years, except for cured basal cell cancer of the skin, or cancer in situ of the cervix.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Spain6 sites

Study site
Barcelona, 08035
Study site
Barcelona, 08036
Study site
Barcelona, 08041
Study site
Madrid, 28041
Study site
Valencia, 46009
Study site
Valencia, 46010

Other trials in Spain

About this study

Official title: An Open-label Study to Evaluate the Effect of Combination Therapy With Epothilone D and Herceptin on Tumor Response in Patients With HER-2 Overexpressing Locally Advanced or Metastatic Breast Cancer

This single arm study will determine the efficacy and safety of an epothilone D and Herceptin combination regimen in patients with HER-2 positive locally advanced or metastatic breast cancer. Epothilone D will be administered intravenously on days 1, 8 and 15 every 4 weeks at a dose not exceeding 100mg/m2. Herceptin will be administered intravenously on a weekly schedule; a 4mg/kg loading dose will be followed by a weekly maintenance dose of 2mg/kg. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Conditions: Breast Cancer
Being tested: Epothilone D, 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.

Epothilone DDrug
Also called RO4598715, KOS-862
≤100 mg/m^2 intravenously (iv) on days 1, 8 and 15 once every 4 weeks
HerceptinDrug
Also called Trastuzumab
4mg/kg iv loading dose, followed by 2mg/kg iv weekly

Study groups in NCT00337649
Study group	Role	What they receive
Phase I - Epothilone D Dose Escalation	Experimental	Not described Receives: Drug: Epothilone D; Drug: Herceptin
Phase II - Epothilone D Maximum Tolerated Dose	Experimental	Not described Receives: Drug: Epothilone D; Drug: Herceptin

What is being measured

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

Phase I: Number of Participants with a Dose-Limiting Toxicity
Measured: From first dose of study treatment until end of Cycle 1 (1 cycle is 28 days)
Phase II: Objective Response Rate (per RECIST criteria)
Measured: From first dose of study treatment until documented response (up to 3 years, 2 months)

Secondary outcomes (4)

Phase II: Duration of Response
Measured: From date of objective response until progressive disease or death, whichever occurs first (up to 3 years, 2 months)
Phase II: Time to Tumor Progression
Measured: From first dose of study treatment until progressive disease or death, whichever occurs first (up to 3 years, 2 months)
Phase I: Plasma Concentration of Epothilone D at Specified Timepoints
Measured: Cycle 1 Days -2, -1, and 1; Cycle 2 Days 1 15-17 (1 cycle is 28 days)
Number of Participants with at Least One Adverse Event
Measured: From first dose of study treatment until 28 days after last dose (up to 3 years, 2 months)

Timeline

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

May 2004Jul 2007

First posted16 Jun 2006 (estimated)
Study startMay 2004
Primary completionJul 2007
Study completionJul 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00337649
Sponsor's protocol ID: NO17328
Status last verified: Apr 2023
First submitted: 15 Jun 2006
Last updated: 28 Apr 2023
Results posted: No

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

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Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Study to Evaluate the Effect of Combination Therapy With Epothilone D and Herceptin on Tumor Response in Patients With HER-2 Overexpressing Locally Advanced or Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT00337649
Acronym / sponsor ID: NO17328
Conditions: Breast Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: May 2004
Primary completion: Jul 2007 (actual)
Study completion: Jul 2007 (actual)
First posted: 16 Jun 2006 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Phase I - Epothilone D Dose Escalation	Experimental	Drug: Epothilone D, Drug: Herceptin
Phase II - Epothilone D Maximum Tolerated Dose	Experimental	Drug: Epothilone D, Drug: Herceptin

Who may qualify

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

Key inclusion criteria (5 listed)

women >=18 years;
locally advanced or metastatic breast cancer;
HER-2 overexpression (FISH + or IHC 3+);
>=1 measurable lesion;
up to one prior anthracycline-based chemotherapy regimen in a metastatic setting.

Key exclusion criteria (4 listed)

pre-existing neuropathy >=grade 2;
known CNS metastases;
congestive heart failure, or myocardial infarction within the last 6 months;
previous malignancies in last 5 years, except for cured basal cell cancer of the skin, or cancer in situ of the cervix.

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
Epothilone DAlso: RO4598715, KOS-862≤100 mg/m^2 intravenously (iv) on days 1, 8 and 15 once every 4 weeks	Drug	Phase I - Epothilone D Dose Escalation, Phase II - Epothilone D Maximum Tolerated Dose
HerceptinAlso: Trastuzumab4mg/kg iv loading dose, followed by 2mg/kg iv weekly	Drug	Phase I - Epothilone D Dose Escalation, Phase II - Epothilone D Maximum Tolerated Dose

Primary outcome

Phase I: Number of Participants with a Dose-Limiting Toxicity
Time frame: From first dose of study treatment until end of Cycle 1 (1 cycle is 28 days)
Phase II: Objective Response Rate (per RECIST criteria)
Time frame: From first dose of study treatment until documented response (up to 3 years, 2 months)

4 secondary outcomes

Phase II: Duration of Response
Time frame: From date of objective response until progressive disease or death, whichever occurs first (up to 3 years, 2 months)
Phase II: Time to Tumor Progression
Time frame: From first dose of study treatment until progressive disease or death, whichever occurs first (up to 3 years, 2 months)
Phase I: Plasma Concentration of Epothilone D at Specified Timepoints
Time frame: Cycle 1 Days -2, -1, and 1; Cycle 2 Days 1 15-17 (1 cycle is 28 days)
Number of Participants with at Least One Adverse Event
Time frame: From first dose of study treatment until 28 days after last dose (up to 3 years, 2 months)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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RecruitingPhase 2
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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 1/2 study testing Epothilone D and Herceptin in people with Breast Cancer, run by Hoffmann-La Roche at 6 sites in Spain.

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 5 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: finished, as of the sponsor's last update on 28 Apr 2023. 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 Spain. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Phase I: Number of Participants with a Dose-Limiting Toxicity (time frame: From first dose of study treatment until end of Cycle 1 (1 cycle is 28 days)). The study lists 2 primary outcomes in all. 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 NCT00337649.

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 28 Apr 2023.