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Randomized Double-blind Study to Compare Two Neo-adjuvant Treatments: an Anti-aromatase (Letrozole) vs a SERM (Tamoxifen) for Postmenopausal Women With ER+ Breast Adenocarcinoma: Effect on Intermediate Predictive Biological Response to Treatment.


Phase 3
65 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Randomized Double-blind Study to Compare Two Neo-adjuvant Treatments: an Anti-aromatase (Letrozole) vs a SERM (Tamoxifen) for Postmenopausal Women With ER+ Breast Adenocarcinoma: Effect on Intermediate Predictive Biological Response to Treatment.


OBJECTIVES:

Primary

- Investigate the changes in Ki67 and PCNA in postmenopausal women with estrogen
receptor-positive (ER+) breast cancer after 4 months of treatment with letrozole vs
tamoxifen citrate.

Secondary

- Compare the response after 4 months of therapy.

- Define the resistant forms of cancer in patients treated with these regimens.

- Define the molecular signature predictive of sensitivity or resistance to ER+ breast
adenocarcinoma by gene and serum protein profiling.

- Search for serum protein profiles predictive of recurrence-free interval.

OUTLINE: Patients are randomized into 1 of 2 intervention arms.

- Arm I: Patients receive oral letrozole once daily for 16 weeks.

- Arm II: Patients receive oral tamoxifen citrate once daily for 16 weeks. Patients in
both arms then undergo surgery.

Blood and tumor tissue samples are collected at baseline and after completion of neoadjuvant
therapy for changes in Ki67 and PCNA and serum protein profiling analysis.

After completion of study therapy, patients are followed up every 6 months for 3 years, and
then once a year for 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed invasive breast adenocarcinoma

- Clinically T2 tumor and/or > 1 cm by echography

- Estrogen receptor (ER)-positive and > 10% of the tumor cells positive

- No ER-negative disease

- No prior breast cancer

- No metastatic or inflammatory breast adenocarcinoma

PATIENT CHARACTERISTICS:

- Postmenopausal

- No cardiac function that could contraindicate surgery or medical treatment (e.g.,
radiotherapy and/or chemotherapy)

- No prior malignancies within the past 5 years except for nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No mental incapacitation that would preclude consent

- No contraindication to tamoxifen citrate or letrozole

PRIOR CONCURRENT THERAPY:

- More than 8 days since prior hormone-replacement therapy or other treatment (i.e.,
phytoestrogen) for menopause

- No concurrent therapy that would modify the expression of the genes regulated by
estrogen

- No concurrent participation in another clinical study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Changes in Ki67 and PCNA after 4 months of treatment with letrozole vs tamoxifen citrate

Safety Issue:

No

Principal Investigator

Philippe Rouanet, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Val d'Aurelle - Paul Lamarque

Authority:

Unspecified

Study ID:

CDR0000638373

NCT ID:

NCT00949598

Start Date:

December 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • estrogen receptor-positive breast cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms

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