Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT00814567
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of low-risk early stage breast cancer, meeting the following criteria:
* Invasive adenocarcinoma
* No invasive carcinoma of classical lobular type
* lympho-vascular invasion present or absent
* Tumor size pathologically determined to be ≤ 3.0 cm in diameter (pT1-2) (\< 3.1 cm maximum microscopic diameter of invasive component)
* Unifocal disease
* Grade I, II, or III disease
* Axillary lymph nodes negative or 1-3 nodes positive (pN0 or pN+(1-3))
* Must have undergone breast conservation surgery with or without adjuvant systemic therapy
* Minimum microscopic margin of non-cancerous tissue ≥ 2 mm (excluding deep margin if this is at deep fascia)
* At low risk of local recurrence after radiotherapy (\< 1% annual risk local recurrence)
* No prior mastectomy
* No blood-borne metastases
PATIENT CHARACTERISTICS:
* No prior malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior endocrine therapy or chemotherapy
* Neoadjuvant endocrine therapy allowed provided the tumour is \< 3.0 cm and all other inclusion criteria are met
* No primary endocrine therapy as a replacement for surgery
* No concurrent chemoradiotherapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT00814567
Study Brief:
Protocol Section:
NCT00814567