A Translational Randomized Phase III Study Exploring the Effect of the Addition of Capecitabine to Carboplatine Based Chemotherapy in Early Triple Negative Breast Cancer

Who is this study for? Adult patients with triple negative breast cancer
What treatments are being studied? capecitabine
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Primary aim: To compare the effect on pathologic complete response (pCR) rate of adding capecitabine to carboplatin based preoperative chemotherapy in early ER-negative and HER2-negative breast cancer. Pembrolizumab is allowed in both arms after approval for TNBC 2022.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Signed written informed consent approved by the Ethical Review Board (IRB).

• Age ≥ 18 to \< 76 years.

• Histologically confirmed unilateral adenocarcinoma of the breast where neoadjuvant chemotherapy followed by definitive surgery is planned.

• Node positive disease (N1-3) or if clinically N0 Tumor size \>20 mm. When deciding T-stage the following hierarchy applies,

∙ MRI

‣ Ultrasound

‣ Mammography

‣ Clinical examination

• ER negative tumor defined by at least one the following:

∙ ER \< 1% cells positive by immunohistochemistry (IHC) or ER ≤ 10% cells positive by IHC and basal-like subtype using gene expression analysis

‣ ER \< 10% cells positive by IHC and PgR \< 10% cells positive by IHC

• HER2-normal tumor defined according to applicable national guidelines

• Consent for germline mutation screening for BRCA1, BRCA2 and other inherited breast cancer associated genes.

• WHO performance status 0 or 1.

• Negative pregnancy test in women of childbearing potential (premenopausal or \<12 months of amenorrhea post-menopause and who have not undergone surgical sterilization).

⁃ Willingness of female patients of childbearing potential, male patients, and their sexual partners to use an effective means of contraception during the treatment period and at least 6 months thereafter.

⁃ Willingness by the patient to undergo treatment and study related procedures according to the protocol.

Locations
Other Locations
Denmark
Aalborg Universitetshospita
RECRUITING
Aalborg
Rigshospitalet
RECRUITING
Copenhagen
Sydvestjysk Sygehus
RECRUITING
Esbjerg
Nordsjællands Hospital
RECRUITING
Hillerød
Regionsjælland Næstved Sygehus
RECRUITING
Næstved
Sønderborg sygehus
RECRUITING
Sønderborg
Vejle Hospital
NOT_YET_RECRUITING
Vejle
Vejle syghus
RECRUITING
Vejle
Sweden
Södra Älvsborgs Hospital
RECRUITING
Borås
Gävle hospital, Department of Oncology
RECRUITING
Gävle
Sahlgrenska University Hospital, Department of Oncology
RECRUITING
Göteborg
Halmstad Hospital, Department of Surgery
NOT_YET_RECRUITING
Halmstad
Ryhov Hospital
RECRUITING
Jönköping
Karlstad Hospital
RECRUITING
Karlstad
Centralsjukhuset i Kristianstad
RECRUITING
Kristianstad
Skåne University Hospital, Department of Oncology
RECRUITING
Malmö
Örebro University Hospital, Department of Oncology
RECRUITING
Örebro
Capio S:t Göran Hospital, Department of Oncology
RECRUITING
Stockholm
Södersjukhuset, Department of Oncology
RECRUITING
Stockholm
Sundsvall hospital
RECRUITING
Sundsvall
Norrland University Hospital, Department of Oncology
RECRUITING
Umeå
Academical Hospital, Department of Oncology
RECRUITING
Uppsala
Västmanlands Hopsital Västerås
RECRUITING
Västerås
Växjö Hospital, Department of Oncology
RECRUITING
Växjö
Contact Information
Primary
Niklas Loman, MD, PhD
niklas.loman@med.lu.se
+46 46 17 75 20
Backup
Liliya Shcherbina, PhD
nordictrip.onkologi@skane.se
Time Frame
Start Date: 2019-12-20
Estimated Completion Date: 2035-06-30
Participants
Target number of participants: 325
Treatments
Active_comparator: Arm A (Platinum-based dose dense EC):
ddEC x 4 + pembrolizumab→ PK x 4 + pembrolizumab, Two-weekly epirubicin/cyclophosphamide (EC) x 4 (epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2), followed after a three-week interval by three-weekly carboplatin x 4 (AUC = 5) together with weekly paclitaxel x 12 (80 mg/m2). Pembrolizumab is given as a 400 mg iv dosis every 6 weeks for the duration of preoperative chemotherapy.\*
Experimental: Arm B (Platinum-based with capecitabine):
CEX x 4→ PK x 4, Three-weekly cyclophosphamide/epirubicin/capecitabine (CEX) (epirubicin 75 mg/m2, cyclophosphamide 600 mg/m2 and capecitabine 900 mg/m2) x 4, followed after a three-week interval by three-weekly carboplatin x 4 (AUC = 5) together with weekly paclitaxel x 12 (80 mg/m2).Pembrolizumab is given as a 400 mg iv dosis every 6 weeks for the duration of preoperative chemotherapy.\*~\*The addition of pembrolizumab is strongly recommended to all participating patients. However, patients with a documented contraindication, or unwilling to receive immunotherapy may be included in the study without the administration of pembrolizumab.
Authors
Nina Letter al-Ayoubi
Sponsors
Collaborators: Danish Breast Cancer Cooperative Group, Swedish Breast Cancer Group
Leads: Lund University Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials