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Breast CancerPhase 2NCT00130507

Benefit of Adding Trastuzumab to Second Line Chemotherapy in Breast Cancer Patients Previously Treated With Trastuzumab

A Phase 2 study testing Vinorelbine, Capecitabine and Trastuzumab in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 1 site in Spain.

Terminated

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

Official record
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Trial summary

Eligible patients must receive vinorelbine plus capecitabine, with or without trastuzumab, until disease progression or unbearable toxicity. Cycles will be administered every 3 weeks.Human epidermal growth factor receptor 2 (HER2) status must be locally assessed by immunohistochemistry (IHC). 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?
Vinorelbine, Capecitabine and Trastuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteSpain
Study dates
4 Nov 2005to 25 Jul 2009
Phase
Phase 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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent.
  • Women older than 18 years old.
  • HER2 positive breast cancer with histological diagnoses.
  • Non-operable locally advanced or metastatic disease, previously treated with trastuzumab and taxanes.
  • Measurable or non-measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).
  • Disease progression during or after treatment with trastuzumab and taxanes.
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  • Maximum of 1 previous chemotherapy line for advanced or metastatic disease.
  • Previous radiotherapy is allowed if radiated area is not the only documented lesion.
  • At least 4 weeks since the last administration of antineoplastic treatment and all toxicities resolved.
  • Performance status Eastern Cooperative Oncology Group (ECOG) >=2.
  • Life expectancy of at least 12 weeks.
  • Left Ventricular Ejection Fraction (LVEF) evaluation (>=50%) in previous 4 weeks.
  • Hematology:
  • neutrophils >=1.5 x 10e9/l;
  • platelets >= 100 x 10e9/l;
  • hemoglobin >= 10 mg/dl
  • Hepatic function:
  • total bilirubin <= 1.5 x under normal limit (UNL);
  • Aspartate aminotransferase (SGOT) and Alanine aminotransferase (SGPT) and alkaline phosphatase <= 2.5 x UNL, or <=5 x UNL if hepatic lesions present
  • Renal function:
  • creatinine <= 175 µmol/l (2 mg/dl);
  • creatinine clearance >= 60 ml/min.
  • Patients able to comply with treatment and follow-up.
  • Negative pregnancy test in the previous 14 days. Adequate contraceptive method during treatment and up to 3 months after finalised.
  • Brain metastatic lesions are allowed provided all other criteria are met.
  • Male who met inclusion criteria are eligible.

Who cannot join

  • History of hypersensitivity to vinorelbine, trastuzumab, rat proteins or trastuzumab components.
  • History of dyspnea at rest, or chronic oxygen therapy required.
  • Active infection.
  • Second malignancy, except for cervical in situ carcinoma, basal skin carcinoma, adequately treated. Previous malignancies with a 5 year disease free survival are allowed.
  • Pregnant or lactating women.
  • Any other serious medical pathology, such as congestive heart failure, unstable angina, history of myocardial infarction during the previous year, uncontrolled hypertension or high risk arrhythmias.
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  • History of neurological or psychiatric disorders, which could preclude the patients to free informed consent.
  • Active uncontrolled infection.
  • Active peptic ulcer, unstable diabetes mellitus.
  • Concomitant treatment with other investigational products. Participation in other clinical trials with a non-marketed drug in the 30 previous days before randomization.
  • Concomitant treatment with other therapy for cancer.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Spanish Breast Cancer Research Group (GEICAM)

    San Sebastián de los Reyes, Madrid, 28700

Other trials in Spain

About this study

Official title: Randomized Trial to Assess the Benefit of Adding Trastuzumab to Capecitabine and Vinorelbine as Second Line for HER2positive Breast Cancer Patients With Locally Advanced or Metastatic Disease, Previously Treated With Trastuzumab and Taxanes

Eligible patients must receive vinorelbine plus capecitabine, with or without trastuzumab, until disease progression or unbearable toxicity. Cycles will be administered every 3 weeks.Human epidermal growth factor receptor 2 (HER2) status must be locally assessed by immunohistochemistry (IHC). All 3+ patients are eligible. In 2+ patients, HER2 status must be confirmed by fluorescence in situ hybridization (FISH).

Read the detailed description

Principal outcome is clinical benefit (complete + partial responses + stable disease). Sample size in each arm has been estimated with the Fleming method. Previous data show a clinical benefit rate of vinorelbine plus capecitabine around 50%. The researchers assume trastuzumab can increase it by 20%. With an alpha error of 0.05 and 80% power, 37 patients per arm are needed.

This is a randomised phase II trial. With a minimum expected benefit rate of 50%, at least 36 patients are needed to choose, with a 90% of probability to be right, the best treatment arm, providing it increases benefit rate at least by 15%.

Assuming a drop-out rate of 10%, the total number of patients needed is 82, 41 per treatment arm.

Patients will be stratified as per investigational site, and presence of visceral metastatic lesion (liver, lung, pleura, heart, peritoneum, suprarenal glands). All patients must receive 2 cycles. If no disease progression is detected, treatment must continue until progression or unbearable toxicity.

Conditions
Breast Cancer
Keywords
HER2 positive breast cancer., Progression to trastuzumab and taxanes.
Medical subject headings
Breast Neoplasms

What participants receive

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

Study groups in NCT00130507
Study groupRoleWhat they receive
Arm A: VXActive comparatorVinorelbine and capecitabine (VX): vinorelbine 25 mg/m2 iv, days 1 and 8 each cycle (21 days), followed of capecitabine 825 mg/m2, orally, twice a day, days 1-14 each cycle (21 days).
Receives: Drug: Vinorelbine; Drug: Capecitabine
Arm B: VXHExperimentalVinorelbine, capecitabine and trastuzumab (VXH): vinorelbine 25 mg/m2 iv, days 1 and 8 each cycle (21 days), followed of capecitabine 825 mg/m2, orally, twice a day, days 1-14 each cycle (21 days) and trastuzumab 4 mg/kg iv (loading dose first week), followed by 2 mg/kg weekly.
Receives: Drug: Vinorelbine; Drug: Capecitabine; Drug: Trastuzumab

What is being measured

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

  1. Clinical benefit rate

    Clinical benefit rate is defined as the rate of objective responses (complete responses and partial responses to treatment) and stabilizations, with a minimum duration of 24 weeks.

    Measured: Through study completion, an average of 1 year

Secondary outcomes (5)

  1. Time to progression (TTP)

    Tumor assessments will be performed until disease progression in order to evaluate the TTP. TTP is defined as the time from the date of the first dose to the first date of objectively determined progressive disease. For patients not known to have objectively-determined progressive disease, TTP will be censored at the date of the last objective progression-free assessment. For patients who receive subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression, TTP will be censored at the date of last objective progression-free assessment prior to the initiation of postdiscontinuation systemic anticancer therapy.

    Measured: Through study completion, an average of 1 year

  2. Objective Response Rate (ORR)

    Tumor response will be assessed using RECIST criteria. The best response across all treatment will be recorded. ORR is defined as the percentage of patients with a complete or partial response out of the patients who had measurable disease at baseline.

    Measured: Through study completion, an average of 1 year

  3. Response Duration (RD)

    RD is defined as the time from the date when the measurement criteria are met for complete response (CR) or partial response (PR) (whichever status is recorded first) until the date of first observation of disease progression or death occurred. For responding patients not known to have died as of the data cut-off date and who do not have progression, duration of response will be censored at the date of last visit with adequate assessment. For responding patients who receive subsequent anticancer therapy (after discontinuation from the study treatment) prior to progression, duration of response will be censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy.

    Measured: Through study completion, an average of 1 year

  4. The Number of Participants Who Experienced Adverse Events (AE)

    All AE suffered by patients will be recorded and graduated by the NCI CTCAE v1.0.

    Measured: Through study completion, an average of 1 year

  5. Overall Survival (OS)

    OS was defined as the time elapsed from first treatment until death from any cause.

    Measured: Through study completion, an average of 1 year

Timeline

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

  1. First posted15 Aug 2005 (estimated)
  2. Study start4 Nov 2005
  3. Primary completionJun 2009
  4. Study completion25 Jul 2009

Why it stopped: A new alternative treatment caused the decrease in the rhythm of recruitment.

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00130507
Sponsor's protocol ID
GEICAM 2004-06
Status last verified
Feb 2019
First submitted
12 Aug 2005
Last updated
26 Feb 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vinorelbine, Capecitabine and Trastuzumab in people with Breast Cancer, run by Spanish Breast Cancer Research Group 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 26 inclusion and 11 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 26 Feb 2019. 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 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?

The study was stopped early (reason given: A new alternative treatment caused the decrease in the rhythm of recruitment.). Results are not available in the source record.

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?

Clinical benefit rate (time frame: Through study completion, an average of 1 year). 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 NCT00130507.

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 26 Feb 2019.

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