Establishment of Molecular Profiling for Individual Clinical Routine Treatment Decision in Early Breast Cancer

Plain-language summary

This study evaluates the use of tumor molecular profiling (multi-parameter tests) to support treatment decisions in patients with early breast cancer. It includes patients aged 18 and older with hormone receptor-positive, HER2-negative early breast cancer without lymph node involvement. It is being conducted as a study with no assigned phase and is currently active but not recruiting new participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Active, not recruiting

Sponsor

Oslo University Hospital

Intervention

Multi-parameter tests

Start date

10/29/2018

Estimated completion

12/31/2043

Countries

Norway

Related genes

Locations

• Bergen, Norway
• Drammen, Norway
• Sarpsborg, Norway
• Oslo, Norway
• Skien, Norway

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Written informed consent (informed consent document approved by the Independent Ethics Committee \[IEC\]) obtained prior to any study-specific procedure
2. Female or male age ≥ 18 years
3. Able to comply with the protocol
4. Primary surgery completed or if re-resection needed, a change from pT1 to pT2 categorization is not expected
5. Histologically confirmed adenocarcinoma of the breast ≤ 5.0 cm in size (pT1-2) without metastasis to regional lymph nodes (pN0) or ≤ 20 mm in size (pT1) with lymph node micrometastases only (pN1mi)
6. Primary tumor concluded as hormone receptor positive (ER ≥ 1%), HER2 negative.

Exclusion Criteria:

1. Metastasis to regional lymph nodes or distant sites/organs.
2. Previous treatment for localized breast cancer. Previous treatment for DCIS is allowed.
3. HER2 positive
4. ER and PgR negative tumor (\< 1% expression)
5. Other concomitant or earlier carcinoma less than five years prior to the breast cancer diagnosis, except for basal cell carcinoma and in situ cervix cancer
6. Use of or participation in intervention trials testing treatment with any investigational anti-cancer drug. Participation in other types of intervention trials is allowed (such participation needs to be registered).
7. Evidence of any other disease or condition that by the investigator is considered to impede follow-up of the patients.