№ files_lp_4_process_3_081441
File format: docx Character count: 2398 File size: 263 KB
Clinical trial eligibility criteria document outlining inclusion and exclusion conditions for participation in an international phase 3 randomized double-blind placebo-controlled study evaluating denosumab for prevention of breast cancer in women with BRCA1 germline mutation.
Study ID: A211801
Study name: BRCA-P
Document type: Clinical trial eligibility criteria summary
Study type: Randomized, double-blind, placebo-controlled clinical trial
Phase: Phase 3
Geographic scope: International multi-center study
Medical field: Oncology
Target condition: Breast cancer prevention in BRCA1 germline mutation carriers
Investigational drug: Denosumab
Control: Placebo
Population: Women with confirmed deleterious or likely deleterious BRCA1 germline mutation aged 25–55 years
Key inclusion criteria: No evidence of breast cancer by MRI or mammography and clinical breast examination within 6 months, no clinical evidence of ovarian cancer, ECOG performance status 0–1, written informed consent
Key exclusion criteria: Prior bilateral mastectomy, history of breast or ovarian cancer, prior denosumab use, pregnancy or lactation, clinically relevant hypocalcaemia, certain prior hormonal or investigational treatments, significant medical or psychiatric conditions, active hepatitis B, hepatitis C, or HIV infection
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.

Don’t have cryptocurrency yet?

You can still complete your purchase in a few minutes:
  1. Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
  2. In the app, tap Send.
  3. Select network, paste our wallet address.
  4. Send the exact amount shown above.
After sending, paste your TXID (transaction ID) and your email to receive the download link. Need help? Contact support and we’ll guide you step by step.

The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
ACMG/AMP Classification Rules Specified for BRCA1 & BRCA2 ENIGMA Variant Curation Expert Panel, Classification Criteria V1.2 2024-11-18
Year: 2024
Region / City: N/A
Topic: BRCA1 & BRCA2 variant classification
Document type: Classification guidelines
Organization / Institution: ACMG/AMP, ENIGMA
Author: Variant Curation Expert Panel
Target audience: Geneticists, researchers, healthcare professionals
Period of validity: N/A
Approval date: 2024-11-18
Modification date: N/A
ACMG/AMP Classification Rules Specified for BRCA1 & BRCA2ENIGMA Variant Curation Expert Panel, Classification Criteria V1.0 2023-04-27
Year: 2023
Region / City: Global
Topic: Variant Classification
Document Type: Technical Specification
Organization / Institution: ACMG/AMP, ENIGMA Variant Curation Expert Panel
Author: Unknown
Target Audience: Researchers, Geneticists, Clinicians
Period of Validity: Ongoing
Approval Date: 2023-04-27
Date of Changes: None
Supplemental data 1. Restrictions used in the construction of the mutated BRCA1 model
Note: Year
Topic: Genetic Research
Document Type: Supplementary Data
Target Audience: Researchers, Geneticists
Topics: A211801 BRCA-P BRCA1