Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age40+
SponsorInstitut Cancerologie de l'Ouest
About this trial
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.
This mutilating surgical management contrasts with the excellent prognosis of this pathology and considerably alters the quality of life of patients.
Neoadjuvant hormone therapy has shown its efficacy in hormone-dependent infiltrating ductal carcinomas and offers the possibility of conservative surgery after hormone therapy.
Adjuvant hormone therapy with Tamoxifen or anti-aromatase drugs has shown its efficacy in the prevention of homo or contralateral recurrence.
The HORNEO 01 trial fits perfectly in the current context of surgical de-escalation of ductal carcinomas in situ. The objective of the study is to evaluate the impact of neoadjuvant hormone therapy on the surgical management of extensive DCIS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Invasive breast carcinoma
Lobular carcinoma in situ
pN+ patient
Indication for conservative surgery
Trial design
Design model
Single group
Treatments tested in this trial
Tamoxifen 20 mg
DrugTamoxifen will be initiated in non menopausal patients orally for 6 months in a neoadjuvant situation.
Anastrozole 1Mg Tab
DrugAnastrozole will be initiated in menopausal patients orally for 6 months in a neoadjuvant situation.
Treatment groups
262 Participants
are divided into 1 treatment groupGroup A: Extended ductal carcinoma in situ with mastectomy indicationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Efficacy of neoadjuvant hormonotherapy
% of conservative surgeries performed after hormonotherapy
Time frame
6 months of hormonotherapySecondary outcomes
1
Disease-free survival (DFS)
DFS rates at 5 and 10 years post-surgery
Time frame
5 and 10 years post-surgery2
Overall survival (OS)
Survival rates at 5 and 10 years post-surgery
Time frame
5 and 10 years post-surgery3
Pathologic Complete Response (pCR)
Pathologic complete response is defined as no residual invasive cancer in the surgical specimen
Time frame
6 months of hormonotherapy4
Predictive factors of response
Response is defined by the variation in the diameter of the longest dimension of the target lesion measured by MRI
Time frame
3 and 6 months of hormonotherapySponsors and contacts
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Source ClinicalTrials.gov