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Phase II Trial Assessing Neoadjuvant Therapy With FEC 100 Followed by Taxotere® (Docetaxel) Plus Vectibix® (Panitumumab) in Patients With Operable, HR and Her-2 Negative Breast Cancer. TVA Study


Phase 2
18 Years
N/A
Not Enrolling
Female
Pathological Response Rate

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Trial Information

Phase II Trial Assessing Neoadjuvant Therapy With FEC 100 Followed by Taxotere® (Docetaxel) Plus Vectibix® (Panitumumab) in Patients With Operable, HR and Her-2 Negative Breast Cancer. TVA Study


Inclusion Criteria:



- Age ³ 18.

- Performance status £ 2 (according to WHO criteria).

- Patient has histologically confirmed, non-metastatic breast cancer, with a clinical
tumour diameter of ³ 2 cm

- HR negative and Her-2 negative.

- Clinical stage II and IIIa.

- Patients not previously treated by surgery, radiotherapy, hormone therapy or
chemotherapy.

- Haematology:

- Neutrophil count ≥1.5x109/L

- Platelet count ≥100x109/L

- Leucocyte count > 3,000/mm

- Hb> 9g/dl

- Hepatic Function:

- Total bilirubin ≤ 1.5 time the upper normal limit (UNL)

- ASAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver
metastases

- ALAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver
metastases

- Alkaline phosphatase ≤ 2.5 time the upper normal limit (UNL)

- Renal Function

- Creatinine clearance ≥50 mL/min and serum creatinine ≤1.5xUNL

- Metabolic Function

- Magnesium ≥ lower limit of normal.

- Calcium ≥ lower limit of normal.

- Patient with no progressive heart disease, and for whom anthracyclines are not
contraindicated (normal FEV).

- Patient has signed the consent forms for participation before inclusion in the trial.

- Member of a Social Security scheme (or a beneficiary of such a scheme) according to
the provisions of the law of 9 August 2004.

Exclusion Criteria:

- Male patients.

- Her-2 positive patients

- Subject pregnant or breast feeding, or planning to become pregnant within 6 months
after the end of treatment.

- Subject (male or female) is not willing to use highly effective methods of
contraception (per institutional standard) during treatment and for 6 months (male or
female) after the end of treatment.

- Any form of breast cancer other than those described in the inclusion criteria,
particularly inflammatory and/or overlooked forms (T4b or T4d).

- Non-measurable tumour.

- Patients have already undergone surgery for their disease or have had primary
axillary dissection.

- Patient has already been treated for new breast cancer.

- Patient is a ward.

- Patient has a history of second cancer, with exception of in situ cervical cancer or
basocellular skin cancer which is regarded as cured.

- Patient has another disease which is deemed incompatible with the patient being
included in the protocol.

- Heart or kidney failure, medullary, respiratory or liver failure.

- Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
arrhythmia) £ 1 year before enrollment/randomization

- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or
evidence of interstitial lung disease on baseline chest CT scan

- Significant neurological or psychiatric abnormalities.

- Symptomatic or progressive disorder of the central nervous system (CNS) or metastasis
at the initial check-up.

- Peripheral neuropathy > grade 2 (NCI-CTCAE criteria, Version 3.0).

- History of allergy to polysorbate 80.

- Concomitant treatment with a trial drug, participation in another clinical trial
within < 30 days or previous chemotherapy.

- Patient with no fixed address in the next 6 months or living at a distance from the
treatment centre so it is difficult to check her progress.

- Prior anti-EGFr antibody therapy (e.g.:cetuximab) or treatment with small molecule
EGFr tyrosine kinase inhibitors (e.g.: erlotinib).

- Known previous or ongoing abuse of narcotic drug, other medication or alcohol.

- Any investigational agent within 30 days before initiation of study treatment.

- Must not have had a major surgical procedure within 28 days of initiation of
treatment.

- Subject unwilling or unable to comply with study requirements.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the rate of complete histological response, according to Chevallier's classification

Outcome Time Frame:

after 24 weeks of treatment

Safety Issue:

No

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

Getna7/CJP1.0

NCT ID:

NCT00933517

Start Date:

September 2009

Completion Date:

October 2011

Related Keywords:

  • Pathological Response Rate
  • breast cancer, neoadjuvant therapies, chemotherapy, targeted therapy
  • Breast Neoplasms

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