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New treatment option for Ductal Carcinoma in Situ
Official title Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ
ClinicalTrials.gov ID: NCT04666961
What this study is testing
What is Tamoxifen 20 mg?
Tamoxifen 20 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ductal carcinoma in situ.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Ductal carcinoma in situ (DCIS) accounts for approximately 20% of newly diagnosed breast cancer cases. Of these women, 20% require radical management in the form of mastectomy because of the extent of the lesions, which most often manifest as diffuse microcalcifications.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, women only
You may be able to join if
- Patient ≥ 40 years old
- Histological diagnosis of ductal carcinoma in situ without infiltrating contingent
- Clinical T0N0
- Estrogen receptor positive (OR+) regardless of progesterone receptor (PR) status
- Indication for mastectomy
You likely can't join if
- Invasive breast carcinoma
- Lobular carcinoma in situ
- pN+ patient
- Indication for conservative surgery
- Contraindications to anastrozole or tamoxifen
- Concomitant treatments that may interact and reduce the how well it works of tamoxifen by interaction with cytochrome CYP2D6.
See the full eligibility criteria
- Patient ≥ 40 years old
- Histological diagnosis of ductal carcinoma in situ without infiltrating contingent
- Clinical T0N0
- Estrogen receptor positive (OR+) regardless of progesterone receptor (PR) status
- Indication for mastectomy
- DCIS visible on MRI performed with clip sequence
- Effective contraceptive method for women of childbearing age who are sexually active and who have reported sexual activity.
- Informing the patient and obtaining free, informed and written consent signed by the patient and the investigator.
- Affiliated patient or beneficiary of the social security system.
- Invasive breast carcinoma
- Lobular carcinoma in situ
- pN+ patient
- Indication for conservative surgery
- Contraindications to anastrozole or tamoxifen
- Concomitant treatments that may interact and reduce the how well it works of tamoxifen by interaction with cytochrome CYP2D6.
- Histologically proven multifocal lesion
- Contraindication to breast MRI (pace maker, heart valve, metallic implant, neuronal or peripheral stimulator, severe claustrophobia, ...)
- History of homolateral breast cancer
- Ongoing contralateral breast cancer
- Known mutation BRCA1 BRCA2
- Other cancer in progress at inclusion
- Pregnant woman, or breastfeeding,
- Persons deprived of liberty or under guardianship or trusteeship,
- Impossibility to undergo the medical follow-up of the trial for geographical, social, psychic or psychiatric reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Bordeaux, France
- Montpellier, France
- Nice, France
- Paris, France
- Saint-Herblain, France
- Toulouse, France
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, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Bordeaux, France; Montpellier, France; Nice, France; Paris, France; Saint-Herblain, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.