Breast CancerPhase 1/2NCT02015676

A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer

A Phase 1/2 study testing trastuzumab, paclitaxel and Myocet in people with Breast Cancer, run by Hoffmann-La Roche at 1 site 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

This study will define an optimal chemotherapy dose regimen of Myocet in combination with paclitaxel and intravenous Herceptin and will evaluate the efficacy and safety of this dose regimen in patients with metastatic or locally advanced breast cancer and HER2 overexpression. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Breast Cancer
What is being tested?: trastuzumab, paclitaxel and Myocet
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 1 siteSpain
Study dates: Jul 2001to Sep 2009
Phase: Phase 1/2
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 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

women 18-70 years of age;
metastatic or locally advanced breast cancer;
HER2 overexpression;
>= 1 measurable lesion.

Who cannot join

prior treatment for advanced breast cancer;
prior treatment with Herceptin;
bone or central nervous system metastasis as the only site of disease;
history of another malignancy (except basal cell skin cancer and cancer in situ of the uterine cervix, and contralateral breast cancer) within 5 years of study.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Study site
Madrid, 28027

Other trials in Spain

About this study

Official title: 'A Study of the Effect of First Line Treatment With Paclitaxel and Myocet in Combination With Herceptin on Overall Tumor Response in Patients With Metastatic or Locally Advanced Breast Cancer and HER2 Overexpression.'

Conditions: Breast Cancer
Being tested: trastuzumab, paclitaxel, Myocet
Medical subject headings: Breast Neoplasms

What participants receive

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

trastuzumabDrug
Also called Herceptin
Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression
paclitaxelDrug
60 mg/m^2 IV weekly; dose increased to 70 mg/m^2, and subsequently 80 mg/m^2, after 2 treatment cycles with no evidence of DLT until disease progression
MyocetDrug
40 mg/m^2 IV weekly; dose increased to 50 mg/m^2 IV after 2 treatment cycles with no evidence of DLT for 6 cycles

Study groups in NCT02015676
Study group	Role	What they receive
Trastuzumab, Myocet, Paclitaxel; Phase I	Experimental	Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 40 mg/ square meter (m^2), IV, every 3 weeks, from Week 1; if no dose limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles. Participants also received paclitaxel 60 mg/ m^2, IV, once per week, from Week 19; if no DLT was observed in ≥ 2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression. Receives: Drug: trastuzumab; Drug: paclitaxel; Drug: Myocet
Trastuzumab, Myocet, Paclitaxel; Phase II	Experimental	Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 50 mg/m^2, IV, every 3 weeks, from Week 1 for 6 cycles. Participants also received paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression. Receives: Drug: trastuzumab; Drug: paclitaxel; Drug: Myocet

What is being measured

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

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment
For measurable disease, CR was defined as the disappearance of all clinically detectable disease determined by 2 observations not less than 4 weeks apart; and PR was defined as a 50 percent (%) decrease in the sum of the products of the 2 greatest diameters of all measurable lesions by 2 observations not less than 4 weeks apart, and no appearance of new lesions or progression of any lesion. For immeasurable disease, CR was defined as the complete disappearance of all known disease for at least 4 weeks; and PR was defined as an estimated decrease in tumor size of 50% or more for at least 4 weeks.
Measured: Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)

Secondary outcomes (10)

Time to Disease Progression - Percentage of Participants With an Event
Disease progression was defined as the time from the start of treatment to the date of the first recorded incident of disease progression, or the date of death due any cause. For measurable disease, disease progression was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of greater than (>)2 square centimeters (cm^2), or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of ≥1 cm^2. For immeasurable disease, disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions.
Measured: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Time to Disease Progression
The median time, in months, from the start of treatment to disease progression event.
Measured: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Time to Treatment Response - Percentage of Participants With an Event
Treatment response was defined as the time from the start of treatment to the date of recorded CR or PR of measurable disease.
Measured: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Time to Treatment Response
The median time, in months, from the start of treatment to treatment response event.
Measured: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Duration of Response - Percentage of Participants With an Event
Duration of response was defined as the time from date CR was first recorded to the date progressive disease (PD) was first noted. For measurable disease, PD was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of >2 cm^2, or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of ≥1 cm^2. For immeasurable disease, PD was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions.
Measured: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Duration of Response
The median time, in months, from enrollment to duration of response event to Week 52.
Measured: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Time to Therapy Failure - Percentage of Participants With an Event
Therapy failure was defined as the date of the start of therapy to the date of withdrawal due to adverse events, progressive disease/insufficient therapeutic response, death, failure to return, or refusal of treatment/lack of cooperation/withdrawal of consent. Participants were censored at the last dose of treatment if no event was recorded.
Measured: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Time to Therapy Failure
The median time, in months, from treatment start to therapy failure event. Participants were censored at the last date of treatment if no event was recorded.
Measured: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Overall Survival (OS) - Percentage of Participants With an Event
OS was defined as the time from the date of the start of treatment to the date of death or the last date the participant was known to be alive.
Measured: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Overall Survival
The time, in months, from the start of treatment to OS event. The mean survival time and it's standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
Measured: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)

Timeline

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

Jul 2001Sep 2009

First posted19 Dec 2013 (estimated)
Study startJul 2001
Primary completionSep 2009
Study completionSep 2009

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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02015676
Sponsor's protocol ID: M77035
Status last verified: Feb 2015
First submitted: 3 Dec 2013
Last updated: 12 Mar 2015
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?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 'A Study of the Effect of First Line Treatment With Paclitaxel and Myocet in Combination With Herceptin on Overall Tumor Response in Patients With Metastatic or Locally Advanced Breast Cancer and HER2 Overexpression.'
ClinicalTrials.gov ID: NCT02015676
Acronym / sponsor ID: M77035
Conditions: Breast Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jul 2001
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 19 Dec 2013 (estimated)
Results: Posted 12 Mar 2015

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: 2

Arm	Type	Receives
Trastuzumab, Myocet, Paclitaxel; Phase I	Experimental	Drug: trastuzumab, Drug: paclitaxel, Drug: MyocetParticipants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 40 mg/ square meter (m^2), IV, every 3 weeks, from Week 1; if no dose limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles. Participants also received paclitaxel 60 mg/ m^2, IV, once per week, from Week 19; if no DLT was observed in ≥ 2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression.
Trastuzumab, Myocet, Paclitaxel; Phase II	Experimental	Drug: trastuzumab, Drug: paclitaxel, Drug: MyocetParticipants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 50 mg/m^2, IV, every 3 weeks, from Week 1 for 6 cycles. Participants also received paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

women 18-70 years of age;
metastatic or locally advanced breast cancer;
HER2 overexpression;
>= 1 measurable lesion.

Key exclusion criteria (4 listed)

prior treatment for advanced breast cancer;
prior treatment with Herceptin;
bone or central nervous system metastasis as the only site of disease;
history of another malignancy (except basal cell skin cancer and cancer in situ of the uterine cervix, and contralateral breast cancer) within 5 years of study.

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
trastuzumabAlso: HerceptinInitial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression	Drug	Trastuzumab, Myocet, Paclitaxel; Phase I, Trastuzumab, Myocet, Paclitaxel; Phase II
paclitaxel60 mg/m^2 IV weekly; dose increased to 70 mg/m^2, and subsequently 80 mg/m^2, after 2 treatment cycles with no evidence of DLT until disease progression	Drug	Trastuzumab, Myocet, Paclitaxel; Phase I, Trastuzumab, Myocet, Paclitaxel; Phase II
Myocet40 mg/m^2 IV weekly; dose increased to 50 mg/m^2 IV after 2 treatment cycles with no evidence of DLT for 6 cycles	Drug	Trastuzumab, Myocet, Paclitaxel; Phase I, Trastuzumab, Myocet, Paclitaxel; Phase II

Primary outcome

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment
Time frame: Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
For measurable disease, CR was defined as the disappearance of all clinically detectable disease determined by 2 observations not less than 4 weeks apart; and PR was defined as a 50 percent (%) decrease in the sum of the products of the 2 greatest diameters of all measurable lesions by 2 observations not less than 4 weeks apart, and no appearance of new lesions or progression of any lesion. For immeasurable disease, CR was defined as the complete disappearance of all known disease for at least 4 weeks; and PR was defined as an estimated decrease in tumor size of 50% or more for at least 4 weeks.

10 secondary outcomes

Time to Disease Progression - Percentage of Participants With an Event
Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Time to Disease Progression
Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Time to Treatment Response - Percentage of Participants With an Event
Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Time to Treatment Response
Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Duration of Response - Percentage of Participants With an Event
Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Duration of Response
Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Time to Therapy Failure - Percentage of Participants With an Event
Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Time to Therapy Failure
Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Overall Survival (OS) - Percentage of Participants With an Event
Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
Overall Survival
Time frame: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)

Results and safety

Results posted to the registry on 12 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trastuzumab, Doxorubicin, Paclitaxel; Phase I	15	6
Trastuzumab, Doxorubicin, Paclitaxel; Phase II	48	14
Trastuzumab Doxorubicin, Paclitaxel; Phase I and Phase II	6	3

Primary outcome: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment

Time frame: Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years). Number. Unit: percentage of participants

Measure	Trastuzumab, Doxorubicin, Paclitaxel; Phase II n = 54
CR	51.85
PR	46.30

Population analysed: All participants enrolled in Phase II of this study were included in the analysis.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: BL, and Weeks 7, 13, 19, every 8 weeks thereafter until end of study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trastuzumab, Doxorubicin, Paclitaxel; Phase I & II	26 of 69 (37.7%)	63 of 69 (91.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Clinical Trials study chair

Hoffmann-La Roche

1 site 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 trastuzumab, paclitaxel and Myocet in people with Breast Cancer, run by Hoffmann-La Roche at 1 site 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 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: finished, as of the sponsor's last update on 12 Mar 2015. 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 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?

Yes. Results are posted in the registry (first posted 12 Mar 2015). 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 Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment (time frame: Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 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 NCT02015676.

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 12 Mar 2015.