Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer

ARCAGY/ GINECO GROUP

Status and phase: Completed; Phase 3

Conditions: Metastatic Breast Cancer

Treatments: Drug: Exemestane; Drug: Celecoxib; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00525096

CELAROM

Details and patient eligibility

About

To discover if the adding of a coxib increases the efficacy of the Aromasine.

Enrollment: 157 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Femal patient aged > 18 years

• Histologically proven breast cancer

• Menopausal patient according to the following definition:

  • amenorrhoea > 1 year or menopause affirmed by a rate of oestradiol or hypophyseal gonadotrophin
  • surgical ovariectomy
  • treatment by LHRH analog
  • ovarian suppression by radiotherapy
  • amenorrhoea induced by chemotherapy > 1 year

• Oestradiol and/or progesterone positive receptors

• Presence of one or several metastatic lesion:

  • mesurable lesion
  • bone metastase were detected by bone scintigraphy

• Patient who can have received:

  • Adjuvant chemotherapy and/or hormonotherapy (Tamoxifen)
  • Metastatic Treatment by chemotherapy

• PS < 2

• Adequate biological values

• Patient who has clearly given her consent by signing on informed consent form prior to participation

Exclusion criteria

• Patient previously treated with hormonotherapy in metastatic phase
• Antecedent of treatment with aromatase inhibitors
• local relapse (with the exception of cutaneous thoracic nodes)
• Patient with only one metastatic lesion like: pleurisy , ascites, lung Lymphangitis carcinomatosa

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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157 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Aromasin + placebo in place of Celebrex

Treatment:

Drug: placebo

Drug: Exemestane

Celebrex

Experimental group

Description:

Aromasin + Celebrex

Treatment:

Drug: Celecoxib

Drug: Exemestane