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Multicenter (Phase II) Study of Oncoplastic Surgical Techniques for Breast Conservation in Breast Cancers


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Multicenter (Phase II) Study of Oncoplastic Surgical Techniques for Breast Conservation in Breast Cancers


OBJECTIVES:

Primary

- Evaluate the percentage of histologically healthy margins maintained during resection
in women with breast cancer.

Secondary

- Evaluate local recurrence at 5 years.

- Evaluate aesthetic results.

- Evaluate quality of life using the QLQC30 and BR23 questionnaires.

OUTLINE: This is a multicenter study.

Patients undergo oncoplastic conservative surgery according to defined modalities across the
various centers.

Quality of life is assessed periodically.

After completion of study treatment, patients are followed every 6 months for 2 years and
then for at least 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Meets 1 of the following criteria:

- Diagnosis of intraductal breast cancer requiring a wide local resection

- Diagnosis of infiltrating ductal breast cancer within range

- Diagnosis of invasive breast cancer that has not responded well to neoadjuvant
treatment

- No multicentric tumor

- No gigantomastia

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- No patients subject to a measure of legal protection or unable to express consent

- No patients deprived of liberty by judicial or administrative decision or
hospitalized without patient consent

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

- No prior radiotherapy to the diseased breast

- No prior adjuvant treatment

- No concurrent participation in another clinical research study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Percentage of histologically healthy margins maintained during resection

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:

CDR0000633327

NCT ID:

NCT00870415

Start Date:

April 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIC breast cancer
  • ductal breast carcinoma
  • invasive ductal breast carcinoma
  • Breast Neoplasms

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