HER-2 Positive Breast CancerPhase 2NCT01340430
Neoadjuvant 5-fluorouracil, Epirubicin and Cyclophosphamide (FEC) Followed by Weekly Paclitaxel and Trastuzumab in Her2 Positive Breast Cancer
A Phase 2 study testing Trastuzumab in people with HER-2 Positive Breast Cancer, run by Lucia Del Mastro,MD at 6 sites in Italy.
Trial summary
The main purpose of this study is to confirm the high pathologic complete response rate after neoadjuvant chemotherapy with FEC followed by weekly paclitaxel and concurrent trastuzumab in Human Epidermal growth factor receptor2 (HER2) positive non operable breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER-2 Positive Breast Cancer
- What is being tested?
- Trastuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 6 sitesItaly
- Study dates
- Mar 2011to Jan 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Performance StatusEstearn Cooperative Oncology Group (ECOG) 0-1
- Histologically confirmed invasive breast cancer,
- Primary tumour greater ≥ 2 cm diameter, measured by clinical examination and mammography or echography or Nuclear Magnetic Resonance (NMR) candidate to neoadjuvant chemotherapy ,
- Any N,
- No evidence of metastasis (M0);
- Over expression and/or amplification of HER2 in the invasive component of the primary tumour according to one of the following definitions:
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- 3+ over expression by immunohistochemistry (IHC) (> 30% of invasive tumour cells),
- 2+ or 3+ (in 30% o less neoplastic cells) overexpression by IHC and in situ hybridization (FISH/CISH) test demonstrating Her2 gene amplication ,
- Her 2 gene amplication by FISH/CISH (ratio > 2.2);
- Known hormone receptor status
- Hematopoietic status:
- absolute neutrophil count ≥ 1.5 x 109/L,
- platelet count ≥ 100 x 109/L,
- Hepatic status:
- serum total bilirubin ≤ 1.5 x ULN. In the case of known Gilbert's syndrome a higher serum total bilirubin (< 2 x ULN) is allowed,
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN,
- alkaline phosphatase ≤ 2.5 times ULN;
- Renal status:
- Creatinine ≤ 2.0 mg/dL;
- Cardiovascular:
- baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by echocardiography or multigate acquisition scan (MUGA);
- For women of childbearing potential negative serum pregnancy test
- Written informed consent.
Who cannot join
- Male gender
- Pregnant or lactating women
- Received any prior treatment for primary invasive breast cancer
- Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (> 180/110), unstable diabetes mellitus, dyspnoea at rest or chronic therapy with oxygen;
- Active or uncontrolled infection,
- Dementia altered mental status or any psychiatric condition that would prevent the under standing or rendering of informed consent,
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- Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies),
- Previous or concomitant malignancy within the past 3 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
- Concurrent disease or condition that would have make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo
Candiolo, TO, 10060
Istituto Nazionale per La Ricerca sul Cancro (IST)
Genoa, Ge, 16132
Ospedale Sacro Cuore - Don Calabria - Oncologia Medica
Negrar, VR, 37024
Ospedale S. Maria della Misericordia - Oncologia Medica
Perugia, PG, 06156
Ospedale Ostetrico Ginecologico S. Anna Di Torino - Oncologia Medica
Torino, To, 10100
Ospedale Mauriziano Umberto I - Ginecologia Oncologica
Torino, TO, 10128
About this study
Official title: Neoadjuvant Therapy With FEC Followed by Weekly Paclitaxel and Concurrent Trastuzumab in Her2 Positive Non Operable Breast Cancer. Phase II Study.
The main purpose of this study is to confirm the high pathologic complete response rate after neoadjuvant chemotherapy with FEC followed by weekly paclitaxel and concurrent trastuzumab in Human Epidermal growth factor receptor2 (HER2) positive non operable breast cancer
- Conditions
- HER-2 Positive Breast Cancer
- Being tested
- Trastuzumab
- Keywords
- her2 positive breast cancer, her2 positive non operable breast cancer, her2 positive locally advanced breast cancer, neoadjuvant trastuzumab, pathologic complete response
- Medical subject headings
- Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Also called herceptin
neoadjuvant FEC (fluorouracil, epirubicin, cyclophosphamide) followed by weekly paclitaxel and concomitant trastuzumab
| Study group | Role | What they receive |
|---|---|---|
| FEC-paclitaxel-trastuzumab | Experimental | fluorouracil 600 mg/m2; epirubicin 90 mg/m2; cyclophosphamide 600 mg/m2 for 4 cycles followed by paclitaxel 80 mg/m2/week in combination with trastuzumab for 12 weeks Receives: Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response
Measured: at definitive surgery within 4 weeks after the last dose of paclitaxel and concurrent trastuzumab
Secondary outcomes (6)
safety and tolerability
safety and tolerability will be assessed by standard clinical and laboratory tests (hematology, serum chemistry). Toxicity grade is defined by the NCI Common Toxicity Criteria (CTC) Adverse Event (AE) v 3.0
Measured: one year
cardiotoxicity
Measured: one year
disease free survival
Measured: one year
overall survival
Measured: one year
rate of conversion from radical to conservative surgery
Measured: definitive surgery
potential biomarkers of trastuzumab resistance
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2015
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER-2 Positive Breast CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucia Del Mastro,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lucia Del Mastro,MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Investigators
- Lucia Del Mastro, MD, Principal investigator, National Institute For Cancer Reasearch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340430
- Sponsor's protocol ID
- NEOHER-021
- Other IDs
- 2010-021600-24
- Status last verified
- May 2024
- First submitted
- 6 Apr 2011
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Therapy With FEC Followed by Weekly Paclitaxel and Concurrent Trastuzumab in Her2 Positive Non Operable Breast Cancer. Phase II Study.
- ClinicalTrials.gov ID
- NCT01340430
- Acronym / sponsor ID
- NEOHER-021
- Conditions
- HER-2 Positive Breast Cancer
- Keywords
- her2 positive breast cancer, her2 positive non operable breast cancer, her2 positive locally advanced breast cancer, neoadjuvant trastuzumab, pathologic complete response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Lucia Del Mastro,MDUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 22 Apr 2011 (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.
The main purpose of this study is to confirm the high pathologic complete response rate after neoadjuvant chemotherapy with FEC followed by weekly paclitaxel and concurrent trastuzumab in Human Epidermal growth factor receptor2 (HER2) positive non operable breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FEC-paclitaxel-trastuzumab | Experimental | Drug: Trastuzumabfluorouracil 600 mg/m2; epirubicin 90 mg/m2; cyclophosphamide 600 mg/m2 for 4 cycles followed by paclitaxel 80 mg/m2/week in combination with trastuzumab for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Performance StatusEstearn Cooperative Oncology Group (ECOG) 0-1
- Histologically confirmed invasive breast cancer,
- Primary tumour greater ≥ 2 cm diameter, measured by clinical examination and mammography or echography or Nuclear Magnetic Resonance (NMR) candidate to neoadjuvant chemotherapy ,
- Any N,
- No evidence of metastasis (M0);
Key exclusion criteria (9 listed)
- Male gender
- Pregnant or lactating women
- Received any prior treatment for primary invasive breast cancer
- Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (> 180/110), unstable diabetes mellitus, dyspnoea at rest or chronic therapy with oxygen;
- Active or uncontrolled infection,
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: herceptinneoadjuvant FEC (fluorouracil, epirubicin, cyclophosphamide) followed by weekly paclitaxel and concomitant trastuzumab | Drug | FEC-paclitaxel-trastuzumab |
Primary outcome
pathologic complete response
Time frame: at definitive surgery within 4 weeks after the last dose of paclitaxel and concurrent trastuzumab
6 secondary outcomes
safety and tolerability
Time frame: one year
cardiotoxicity
Time frame: one year
disease free survival
Time frame: one year
overall survival
Time frame: one year
rate of conversion from radical to conservative surgery
Time frame: definitive surgery
potential biomarkers of trastuzumab resistance
Time frame: one year
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 9 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Lucia Del Mastro, MD principal investigator
National Institute For Cancer Reasearch
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 Trastuzumab in people with HER-2 Positive Breast Cancer, run by Lucia Del Mastro,MD at 6 sites in Italy.
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 23 inclusion and 9 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 9 May 2024. 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 Italy. 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 (time frame: at definitive surgery within 4 weeks after the last dose of paclitaxel and concurrent trastuzumab). 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 9 May 2024.