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Open, Single-Arm Phase II Study Assessing Efficacy of ZARNESTRA™ Combined With Tamoxifen in Patients With Advanced or Metastatic Breast Cancer Expressing the Estrogen and/or Progesterone Receptor


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

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Trial Information

Open, Single-Arm Phase II Study Assessing Efficacy of ZARNESTRA™ Combined With Tamoxifen in Patients With Advanced or Metastatic Breast Cancer Expressing the Estrogen and/or Progesterone Receptor


Inclusion Criteria:



- Histologically proven, metastatic or locally advanced inoperable breast cancer

- Tumor considered potentially hormone-sensitive, i.e. presence by IHC of hormone
receptors for estrogens (ER+ for more than 10% of cells) and/or progesterone (Pg+ for
more than 10% of cells) or both. This expression may have been detected on the
primary tumor or at a metastatic site. The method used will be reassessed by IHC if
it involves a radioligand technique whenever it is possible to obtain histological
material.

- Progressing on treatment with tamoxifen, given either as adjuvant treatment or for
advanced/metastatic breast cancer. Any previous treatment with a steroidal or
nonsteroidal antiaromatase in a neo-adjuvant, adjuvant or metastatic situation is
permitted. Likewise, any previous treatment with chemotherapy and/or herceptin in a
nonmetastatic situation is permitted.

- Post-menopausal patients

- Age > 18 years

- At least one measurable lesion according to the Response Evaluation Criteria for
Solid Tumors (RECIST) criteria; for patients who only have bone metastases, an
evaluable non-irradiated lytic lesion is required

- Performance Status (WHO): PS ≤ 2 (Appendix 1).

- Laboratory tests in accordance with the following criteria:

Neutrophils ≥ 2x109/l,Platelets ≥ 100x109/l,Hemoglobin ≥ 10 g/dl, ASAT, ALAT ≤ 2.5 N , or
< 5 N when liver metastasis,bilirubin ≤ 1.5 N creatinin ≤ 1.5 N

- Signed, written consent before any study-related procedure

Exclusion Criteria:

- Men

- Pre-menopausal patients who are not receiving concurrent LHRH agonist therapy

- ER- and PR-negative patients

- Contraindication to antiestrogens (thromboembolic risk) or ZARNESTRA

- Non metastatic tumor susceptible to management by radiotherapeutic and/or surgical
means

- T4d inflammatory tumor (PEV 2 or 3).

- Short-term, life-threatening lesions: hepatic invasion > 1/3 of liver volume,
pulmonary lymphangitis, uncontrolled cerebral metastases, carcinomatous meningitis

- Sensory neuropathy > or = grade 1 (WHO)

- Previous history of uncontrolled cancers or controlled for less than 5 years, except
basal cell skin cancers and in situ cancers of the cervix.

- Chronic diseases (somatic or psychiatric) with a poor prognosis

- subjects with enzyme-inducing anti-convulsants (e.g., phenytoin, phenobarbital,
carbamazepine) : this treatment is not permitted while taking ZARNESTRA

- Patients who, for family, social, geographic or psychological reasons, could not be
followed up correctly.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the objective response rate when ZARNESTRA is added to administration of tamoxifen in patients suffering from metastatic or advanced inoperable breast cancer, who are progressing on tamoxifen treatment

Principal Investigator

Henri Roché, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud

Authority:

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

Study ID:

03 SEIN 04

NCT ID:

NCT00210028

Start Date:

August 2003

Completion Date:

August 2008

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Zarnestra
  • Tamoxifen
  • estrogen receptor
  • progesterone receptor
  • Breast Neoplasms
  • Neoplasms

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