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Chemotherapy or chemotherapy + hormonotherapy in women over 70 with HER2 receptor-negative but estrogen receptor-positive breast cancer according to their genomic grade
EU CTIS ID: 2024-516996-34-00
What this study is testing
Evaluation of the benefit of adjuvant chemotherapy on overall survival (OS) in the sub group of elderly patients with a high risk of relapse according to Genomic Grade (GG).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Women aged ≥ 70 yo,
- Creatinine clearance prior to GG evaluation (MDRD formula) ≥ 40 mL/min,
- PS (ECOG) ≤ 2,
- Patient able to comply with the protocol,
- Patients must have signed a written informed consent form prior to any study specific procedures, including the agreement for the use of archived tumoral material for genomic screening and data collection
- Patients must be affiliated to a Social Health Insurance.
You likely can't join if
- Any metastatic impairment,
- Any tumor ≥ T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer),
- ER-negative breast cancer (i.e. <10% tumor stained cells by IHC),
- HER2 overexpression, defined as IHC score 3+ or score 2+ and FISH/SISH/CISH positive
- Any chemotherapy, hormonal therapy or radiotherapy for the current breast cancer before surgery,
- PS (ECOG) ≥ 3,
See the full eligibility criteria
- Women aged ≥ 70 yo,
- Creatinine clearance prior to GG evaluation (MDRD formula) ≥ 40 mL/min,
- PS (ECOG) ≤ 2,
- Patient able to comply with the protocol,
- Patients must have signed a written informed consent form prior to any study specific procedures, including the agreement for the use of archived tumoral material for genomic screening and data collection
- Patients must be affiliated to a Social Health Insurance.
- Histologically proven invasive breast cancer (regardless of the type),
- Complete surgery performed before enrolment: radical modified mastectomy or breast conservative surgery, with either a sentinel lymph node procedure or axillary lymph node dissection
- Any N status (pN+ or pN0),
- No clinically or radiologically detectable metastases (M0),
- Oestrogen receptor (ER)-positive, as defined by a ≥ 10% tumor stained cells by immunohistochemistry (IHC),
- HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH negative),
- Normal haematological function prior to GG evaluation : ANC ≥ 1,500/mm3; platelets count ≥ 100,000/mm3; haemoglobin > 9 g/dl,
- Normal hepatic function prior to GG evaluation: total bilirubin ≤ 1.25 ULN; ASAT and ALAT ≤ 1.5 ULN; alkaline phosphatases ≤ 3 ULN
- Any metastatic impairment,
- Any tumor ≥ T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer),
- ER-negative breast cancer (i.e. <10% tumor stained cells by IHC),
- HER2 overexpression, defined as IHC score 3+ or score 2+ and FISH/SISH/CISH positive
- Any chemotherapy, hormonal therapy or radiotherapy for the current breast cancer before surgery,
- PS (ECOG) ≥ 3,
- Any specific contra-indication to the study drugs (including but not limited to hypersensitivity to the study drugs or their components),
- Patient deprived of freedom or under tutelage,
- Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.