Abstract 4733
Background
NA chemotherapy (CT) +/- anti-Her2 treatment of operable breast cancer (BC) is considered a standard option in the management of BC. However, pathologic complete response (pCR) rates with CT in HR+/Her2- BC are usually low: 7% (Luminal A) to 16% (Luminal B). Alternatively, NA endocrine therapy (ET) has not been established as a standard treatment because of low pCRs.
Methods
This is a multicenter phase III, 3rd generation NA trial performed in 34 centers and 7 countries of Middle-East and North Africa (MENA Region). The objective is to investigate the potential role of adding Palbociclib to ET (Fulvestrant +/- Goserelin) compared to ET alone as NA therapy of HR+/Her2- operable BC sensitive to ET. The primary endpoint is pCR with the hypothesis that the addition of Palbociclib would increase the pCR rate from 5% to 15%. Clinical/radiological response, conservative surgery rate, safety, disease-free and OS are secondary endpoints. Exploratory endpoints encompass biomarker serial analysis of liquid biopsies with Quantum Optic and DNA methylation technologies.
Results
A total of 400 pre and post-menopausal pts with stage II and IIIA are planned to be recruited. Oncotype DX is performed upfront in order to eliminate CT candidates. All pts with a recurrence score (RS) < 31 are treated with Fulvestrant (500 mg Day (d.) 1, 14, 28 then q. 28 d. (+/- Goserelin 3.6 mg q.28 d.) for 4 months. Pts with responding/stable disease are then randomized in double blind fashion to Fulvestrant (+/- Goserelin) with either Palbociclib 125mg po daily 3 weeks/4 or placebo. Four additional cycles are delivered before surgery The trial was initiated in 2018. As of April 2019, 196 patients have been enrolled. The majority of them (60%) are pre/peri menopausal. The mean age is 50.5 years (range: 25-83). RS of < 31 was reported in 75% of cases. So far, 96 pts have completed the induction ET and were randomized to ET with or without Palbociclib. End of accrual is expected by end of 2019.
Conclusions
SAFIA trial aims to evaluate whether or not the addition of a CDK 4/6 inhibitor to pts sensitive to ET would validate a neo-adjuvant strategy without CT in luminal operable BC.
Clinical trial identification
NCT03447132.
Editorial acknowledgement
Legal entity responsible for the study
International Cancer Research Group (ICRG).
Funding
Pfizer, AstraZeneca and Genomic Health.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
4410 - Mirvetuximab soravtansine, a folate receptor alpha (FRa)-targeting antibody-drug conjugate (ADC), in combination with carboplatin and bevacizumab: Initial results from a Phase 1b study in patients (pts) with ovarian cancer
Presenter: David Omalley
Session: Poster Display session 2
Resources:
Abstract
5077 - Response to Pegylated Liposomal Doxorubicin (PLD) and Weekly Paclitaxel (wpac) in Platinum Resistant (PR) Ovarian Cancer (OC) by BRCA mutation status
Presenter: Louise Bremer
Session: Poster Display session 2
Resources:
Abstract
3483 - Impact of prior pegylated liposomal doxorubicin (PLD) treatment in recurrent ovarian cancer (ROC): Sub-group analysis from a randomized, open-label study comparing trabectedin (T) and PLD versus PLD alone in ROC (ET743-OVC-3006)
Presenter: Bradley Monk
Session: Poster Display session 2
Resources:
Abstract
5423 - OCTAVE - A phase I study of enadenotucirev, an oncolytic group B adenovirus, in combination with weekly paclitaxel in platinum-resistant epithelial ovarian cancer
Presenter: Iain McNeish
Session: Poster Display session 2
Resources:
Abstract
1385 - Phase I study of low dose whole abdominal radiation therapy (LDWART) in combination with weekly paclitaxel (wP) for platinum resistant ovarian cancer (PROC)
Presenter: Natalie Ngoi
Session: Poster Display session 2
Resources:
Abstract
2090 - Phase 1b/2a study assessing the safety and efficacy of adding AL3818 (Anlotinib) to standard platinum-based chemotherapy in subjects with recurrent or metastatic endometrial, ovarian or cervical carcinoma
Presenter: David Miller
Session: Poster Display session 2
Resources:
Abstract
1960 - Phase I Study of Intraperitoneal TRX-E-002-1 in Subjects with Persistent or Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer: Three-month Follow-up Results of the Dose Escalation Phase
Presenter: Jermaine Coward
Session: Poster Display session 2
Resources:
Abstract
4288 - Hybrid capture-based genomic profiling of circulating tumor DNA (ctDNA) from patients with ovarian cancer
Presenter: Mi Yang
Session: Poster Display session 2
Resources:
Abstract
3433 - Tumor Microvessel Density for predicting Nintedanib activity: data from the randomized CHIVA trial (a GINECO study)
Presenter: Maud Villemin
Session: Poster Display session 2
Resources:
Abstract
3392 - Post-hoc analysis of the nintedanib exposure-response relationships in the CHIVA trial in advanced ovarian cancer: (a GINECO study)
Presenter: Skerdi HAVIARI
Session: Poster Display session 2
Resources:
Abstract