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Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable and/or Locally Advanced Breast Cancer. The INTENS Study


Phase 3
18 Years
70 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable and/or Locally Advanced Breast Cancer. The INTENS Study


Inclusion Criteria:



- Women presenting with large resectable or locally advanced breast cancer (T2 ≥3 cm,
T3, or T4, and/or LN positive)

- Measurable disease (breast and/or lymph nodes)

- No prior surgery other than biopsy and no prior chemotherapy or radiation therapy

- Age ≥18 years and age ≤70 years

- Karnofsky Performance score ≥70%

- Estrogen and/or progesterone receptor analysis performed on the primary tumour in the
biopsy material

- In case the tumor is ER/PgR ³ 50% positive, (neo)adjuvant hormonal therapy in stead
of chemotherapy should be considered (e.g. in TEAM II study)

- Her2/neu receptor analysis performed on the primary tumour in the biopsy material

- Adequate bone marrow function (within 14 days prior to registration): WBC ≥3.0 x
109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l

- Adequate liver function (within 4 weeks prior to start treatment): bilirubin ≤1.5 x
upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase
≤5 x UNL

- Adequate renal function (within 4 weeks prior to start treatment): the calculated
creatinine clearance should be ≥50 mL/min

- Patients must be accessible for treatment and follow-up

- Written informed consent according to the local Ethics Committee requirements

Exclusion Criteria:

- Patients with advanced pulmonary disease of any cause (oxygen dependent)- Peripheral
neuropathy > grade 2 whatever the cause

- Serious other diseases as recent myocardial infarction, clinical signs of cardiac
failure or clinically significant arrythmias

- Evidence of distant metastases (M1)

- Patients with a history of breast cancer

- Patients with a history of another malignancy (except basal cell skin carcinoma and
carcinoma-in-situ of the uterine cervix) within 5 years of study entry- Pregnant or
lactating women, or potentially fertile women not using adequate contraception

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The pathologic complete response rate to neoadjuvant chemotherapy.

Principal Investigator

V.C.G. Tjan-Heijnen

Investigator Role:

Principal Investigator

Investigator Affiliation:

AZM Maastricht

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

IKO 2005-01 / BOOG 2007-02

NCT ID:

NCT00314977

Start Date:

February 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Large resectable breast cancer
  • Locally advanced breast cancer
  • Neoadjuvant therapy
  • Breast Neoplasms

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