Breast CancerPhase 2TRAINNCT00768859
Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study
A Phase 2 study testing paclitaxel, trastuzumab and carboplatin in people with Breast Cancer and HER2 Positive, run by The Netherlands Cancer Institute at 9 sites in Netherlands.
Trial summary
To determine the activity of the combination of paclitaxel, trastuzumab and carboplatin as neo-adjuvant treatment in patients with stage II or III HER2 positive breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, HER2 Positive
- What is being tested?
- paclitaxel, trastuzumab and carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 9 sitesNetherlands
- Study dates
- Sep 2008to May 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed infiltrating breast cancer.
- Stage II or stage III breast cancer.28 'Locally advanced breast cancer' patients are consequently eligible, including those with ipsilateral supraclavicular lymph node metastases. N1 status must have been demonstrated by either fine needle aspiration from an axillary lymph node or by a metastasis of >2 mm in diameter at sentinel node biopsy. Stage IIA patients are eligible if the tumor is >3 cm in diameter or if the tumor is between 2 and 3 cm in diameter but a breast conserving surgery is not possible.
- Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions:
- >10% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+)
- >10% of invasive tumor cells showing moderate complete circumferential membrane staining (score 2+) and demonstrating HER2 gene amplification defined as a FISH ratio of HER2 gene copies to chromosome 17 signals of >2.2. or as >5 HER2 gene copies per nucleus in CISH analysis.
- Patients with a negative or equivocal overall result (FISH test ratio of <2.2, <6.0 HER2 gene copies per nucleus) and staining scores of 0,1+, 2+ or 3+ (in 30% or less neoplastic cells) by IHC are not eligible for participation in the trial.
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- Age ≥18
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (Appendix B)
- Adequate bone marrow function (ANC >1.0 x 109/l, platelets >100 x 109/l)
- Adequate hepatic function (ALAT, ASAT and bilirubin <2 times upper limit of normal)
- Adequate renal function (creatinine clearance >60 ml/min)
- LVEF ≥50% measured by echocardiography or MUGA
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Signed written informed consent
Who cannot join
- No previous radiation therapy or chemotherapy
- No other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.
- No current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection.
- No evidence of distant metastases. Staging examinations must have included a chest radiograph, an ultrasound examination of the liver and an isotope bone scan. Abnormal uptake on the isotope bone scan can only be accepted if MRI, CT-scan, or plain radiograph excludes bone metastases.
- No concurrent anti-cancer treatment or another investigational drug
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Netherlands9 sites
Medisch Centrum Alkmaar
Alkmaar, 1800 AM
NKI-AVL
Amsterdam, 1066 CX
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 HA
Reinier de Graaf Gasthuis
Delft, 2600 AG
Catharina Ziekenhuis
Eindhoven, 5602 ZA
Kennemer Gasthuis
Haarlem, 2035 RC
Leids Universitair Medisch centrum
Leiden, 2300 RC
Medisch Centrum Haaglanden
Leidschendam, 2262 BA
Sint Antonius Ziekenhuis
Nieuwegein, 3430 EM
About this study
To determine the activity of the combination of paclitaxel, trastuzumab and carboplatin as neo-adjuvant treatment in patients with stage II or III HER2 positive breast cancer
- Conditions
- Breast Cancer, HER2 Positive
- Being tested
- paclitaxel, trastuzumab and carboplatin
- Keywords
- breast cancer, HER2 positive, neo-adjuvant, trastuzumab, paclitaxel, carboplatin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel, trastuzumab and carboplatinDrug
paclitaxel; 70 mg/m2 trastuzumab; 2 mg/kg (loading dose 4 mg/kg) carboplatin; AUC = 3
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | paclitaxel, trastuzumab and carboplatin Receives: Drug: paclitaxel, trastuzumab and carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (pCR) rate at surgery
Measured: at the completion of neo-adjuvant chemotherapy
Secondary outcomes (1)
To describe disease-free and overall survival
Measured: during routine follow up visits after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2011
- Study completionMay 2012
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 The Netherlands Cancer InstituteThe 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- G S Sonke, MD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768859
- Sponsor's protocol ID
- M08TRA
- Other IDs
- 2008-000987-18, 2008
- Acronym
- TRAIN
- Status last verified
- May 2012
- First submitted
- 7 Oct 2008
- Last updated
- 11 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study
- ClinicalTrials.gov ID
- NCT00768859
- Acronym / sponsor ID
- TRAIN / M08TRA
- Conditions
- Breast Cancer, HER2 Positive
- Keywords
- breast cancer, HER2 positive, neo-adjuvant, trastuzumab, paclitaxel, carboplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 8 Oct 2008 (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.
To determine the activity of the combination of paclitaxel, trastuzumab and carboplatin as neo-adjuvant treatment in patients with stage II or III HER2 positive breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: paclitaxel, trastuzumab and carboplatinpaclitaxel, trastuzumab and carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically or cytologically confirmed infiltrating breast cancer.
- Stage II or stage III breast cancer.28 'Locally advanced breast cancer' patients are consequently eligible, including those with ipsilateral supraclavicular lymph node metastases. N1 status must have been demonstrated by either fine needle aspiration from an axillary lymph node or by a metastasis of >2 mm in diameter at sentinel node biopsy. Stage IIA patients are eligible if the tumor is >3 cm in diameter or if the tumor is between 2 and 3 cm in diameter but a breast conserving surgery is not possible.
- Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions:
- Patients with a negative or equivocal overall result (FISH test ratio of <2.2, <6.0 HER2 gene copies per nucleus) and staining scores of 0,1+, 2+ or 3+ (in 30% or less neoplastic cells) by IHC are not eligible for participation in the trial.
- Age ≥18
Key exclusion criteria (5 listed)
- No previous radiation therapy or chemotherapy
- No other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.
- No current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection.
- No evidence of distant metastases. Staging examinations must have included a chest radiograph, an ultrasound examination of the liver and an isotope bone scan. Abnormal uptake on the isotope bone scan can only be accepted if MRI, CT-scan, or plain radiograph excludes bone metastases.
- No concurrent anti-cancer treatment or another investigational drug
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 |
|---|---|---|
| paclitaxel, trastuzumab and carboplatinpaclitaxel; 70 mg/m2 trastuzumab; 2 mg/kg (loading dose 4 mg/kg) carboplatin; AUC = 3 | Drug | 1 |
Primary outcome
Pathologic complete response (pCR) rate at surgery
Time frame: at the completion of neo-adjuvant chemotherapy
1 secondary outcome
To describe disease-free and overall survival
Time frame: during routine follow up visits after surgery
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 11 May 2012.
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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.
G S Sonke, MD principal investigator
The Netherlands Cancer Institute
9 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 paclitaxel, trastuzumab and carboplatin in people with Breast Cancer and HER2 Positive, run by The Netherlands Cancer Institute at 9 sites in Netherlands.
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 14 inclusion and 5 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 11 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands. 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 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?
Pathologic complete response (pCR) rate at surgery (time frame: at the completion of neo-adjuvant chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2012.