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Neoadjuvant 5-fluorouracil, Epirubicin and Cyclophosphamide (FEC) Followed by Weekly Paclitaxel and Trastuzumab in Her2 Positive Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01340430
Recruitment Status : Active, not recruiting
First Posted : April 22, 2011
Last Update Posted : October 11, 2018
Information provided by (Responsible Party):
Lucia Del Mastro,MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Brief 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

Condition or disease Intervention/treatment Phase
HER-2 Positive Breast Cancer Drug: Trastuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Therapy With FEC Followed by Weekly Paclitaxel and Concurrent Trastuzumab in Her2 Positive Non Operable Breast Cancer. Phase II Study.
Study Start Date : March 2011
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: FEC-paclitaxel-trastuzumab
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
Drug: Trastuzumab
neoadjuvant FEC (fluorouracil, epirubicin, cyclophosphamide) followed by weekly paclitaxel and concomitant trastuzumab
Other Name: herceptin

Primary Outcome Measures :
  1. pathologic complete response [ Time Frame: at definitive surgery within 4 weeks after the last dose of paclitaxel and concurrent trastuzumab ]

Secondary Outcome Measures :
  1. safety and tolerability [ Time Frame: one year ]
    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

  2. cardiotoxicity [ Time Frame: one year ]
  3. disease free survival [ Time Frame: one year ]
  4. overall survival [ Time Frame: one year ]
  5. rate of conversion from radical to conservative surgery [ Time Frame: definitive surgery ]
  6. potential biomarkers of trastuzumab resistance [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Performance StatusEstearn Cooperative Oncology Group (ECOG) 0-1
  2. Histologically confirmed invasive breast cancer,
  3. Primary tumour greater ≥ 2 cm diameter, measured by clinical examination and mammography or echography or Nuclear Magnetic Resonance (NMR) candidate to neoadjuvant chemotherapy ,
  4. Any N,
  5. No evidence of metastasis (M0);
  6. Over expression and/or amplification of HER2 in the invasive component of the primary tumour according to one of the following definitions:
  7. 3+ over expression by immunohistochemistry (IHC) (> 30% of invasive tumour cells),
  8. 2+ or 3+ (in 30% o less neoplastic cells) overexpression by IHC and in situ hybridization (FISH/CISH) test demonstrating Her2 gene amplication ,
  9. Her 2 gene amplication by FISH/CISH (ratio > 2.2);
  10. Known hormone receptor status
  11. Hematopoietic status:

    1. absolute neutrophil count ≥ 1.5 x 109/L,
    2. platelet count ≥ 100 x 109/L,
  12. Hepatic status:

    1. 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,
    2. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN,
    3. alkaline phosphatase ≤ 2.5 times ULN;
  13. Renal status:

    a. Creatinine ≤ 2.0 mg/dL;

  14. Cardiovascular:

    a. baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by echocardiography or multigate acquisition scan (MUGA);

  15. For women of childbearing potential negative serum pregnancy test
  16. Written informed consent.

Exclusion Criteria:

  1. Male gender
  2. Pregnant or lactating women
  3. Received any prior treatment for primary invasive breast cancer
  4. 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;
  5. Active or uncontrolled infection,
  6. Dementia altered mental status or any psychiatric condition that would prevent the under standing or rendering of informed consent,
  7. Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies),
  8. 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.
  9. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01340430

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Istituto Nazionale per La Ricerca sul Cancro (IST)
Genoa, Ge, Italy, 16132
Ospedale S. Maria della Misericordia - Oncologia Medica
Perugia, PG, Italy, 06156
Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo
Candiolo, TO, Italy, 10060
Ospedale Ostetrico Ginecologico S. Anna Di Torino - Oncologia Medica
Torino, To, Italy, 10100
Ospedale Mauriziano Umberto I - Ginecologia Oncologica
Torino, TO, Italy, 10128
Ospedale Sacro Cuore - Don Calabria - Oncologia Medica
Negrar, VR, Italy, 37024
Sponsors and Collaborators
Lucia Del Mastro,MD
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Principal Investigator: Lucia Del Mastro, MD National Institute For Cancer Reasearch

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Responsible Party: Lucia Del Mastro,MD, md, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy Identifier: NCT01340430     History of Changes
Other Study ID Numbers: NEOHER-021
2010-021600-24 ( EudraCT Number )
First Posted: April 22, 2011    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Lucia Del Mastro,MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:
her2 positive breast cancer
her2 positive non operable breast cancer
her2 positive locally advanced breast cancer
neoadjuvant trastuzumab
pathologic complete response

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antimetabolites, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors