Genetic Expression and Prediction of Response to Neoadjuvant Docetaxel or Doxorubicin in Locally Advanced Breast Cancer

San Carlos Clinical Hospital

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: doxorubicin; Drug: docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT00123929

05/117

Details and patient eligibility

About

After a core biopsy of the tumor is obtained, patients with locally advanced breast cancer are randomized to receive 4 cycles of full dose doxorubicin (75 mg/m2 e3w) or docetaxel (100 mg/m2 e3w). After the fourth cycle, patients are submitted to surgery to ascertain pathological response. They then receive the opposite drug, hormones, Herceptin, and radiation as indicated.

Full description

The aim of the study is to define the genetic signature which predicts the response to single drug doxorubicin versus docetaxel. 250 patients will be included. cDNA microarrays will be produced and the genetic pattern will be correlated with the response to doxorubicin and docetaxel. Secondary aim is the prediction of response by means of IHC determinations (her2, ER, PgR, Ki67, protein TAU), FISH (topoisomerase II alpha, her2) and PCR (topoisomerase II alpha).

Enrollment: 250 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Locally advanced, inoperable breast carcinoma or stage II not amenable to breast preserving surgery (amendment introduced on november 2006)
• Signed informed consent

Exclusion criteria

• Age >75
• Cardiac disease; LEFT <50%
• Hyperbilirubinemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

1

Active Comparator group

Description:

doxorubicin

Treatment:

Drug: doxorubicin

2

Other group

Description:

docetaxel

Treatment:

Drug: docetaxel