Clinical trials: Breast Cancer Surgery
Triple Negative Breast Cancer
Phase I/II, Evaluate the Safety and Efficacy of BLEX 404 With Docetaxel in Patients With Advanced/Metastatic Triple Negative Breast Cancer.
The primary purpose of this study is to determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Docetaxel monotherapy in a 21-day schedule.
- Trial name
- NCT02802423
- Testing
- BLEX 404 Oral Liquid
- Volunteers
- 44 people
- Sponsor
- BioLite, Inc.
Breast Cancer, Breast Cancer Invasive
Specimen PET-CT Imaging for Intraoperative Margin Assessment in Breast Cancer
Breast-conserving surgery (BCS) has become the standard-of-care for surgical management of the majority of women with early-stage breast cancer.
- Conditions
- Breast Cancer, Breast Cancer Invasive, Breast Cancer in Situ
- Trial name
- BrIMA (NCT04999917)
- Testing
- high-resolution PET-CT specimen imaging.
- Where
- Belgium
- Volunteers
- 206 people
- Sponsor
- XEOS Medical
Breast Cancer
Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
This is a Phase 1, open-label, dose escalation study in women with primary, non-recurrent breast cancer undergoing surgery. AVB-620 will be administered prior to surgery.
- Trial name
- NCT02391194
- Testing
- AVB-620
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- Avelas Biosciences, Inc.
Breast Cancer Female, Breast Cancer
Robotic vs. Open NSM for Early Stage Breast Cancer
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
- Conditions
- Breast Cancer Female, Breast Cancer, Breast Cancer, Early-Onset, Breast Disease
- Trial name
- SP NSM (NCT05720039)
- Testing
- Robotic NSM, Open NSM
- Where
- 15 sites in United States
- Volunteers
- 204 people
- Sponsor
- Intuitive Surgical
Breast Cancer
Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before.
- Trial name
- NCT03734029
- Testing
- Trastuzumab deruxtecan (DS-8201a), Capecitabine, Eribulin
- Where
- 208 sites in United States, Austria and 18 more
- Volunteers
- 557 people
- Sponsor
- Daiichi Sankyo
Breast Cancer - Ductal Carcinoma in Situ (DCIS), Breast-Conserving Surgery
Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment
This PMPF study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when including the use of the HLS in the context of breast lumpectomy margin assessment.
- Trial name
- SHIELD (NCT05946759)
- Testing
- Histolog Scanner
- Where
- Germany
- Volunteers
- 54 people
- Sponsor
- SamanTree Medical SA
Cutaneous Breast Cancer
Efficacy and Safety Study of REM-001 Photodynamic Therapy for Treatment of Cutaneous Metastatic Breast Cancer (CMBC)
This is an open-label, single cohort study to confirm dose, assessments and timing of response, to support future studies. The primary objective of the trial is to evaluate cutaneous tumor response within total target treatment…
- Trial name
- NCT05374915
- Testing
- REM-001 photodynamic therapy
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Kintara Therapeutics, Inc.
Breast Cancer
Breast Cancer Detection in Breast Surgical Specimens With the Histolog Scanner, Slide-free Confocal Microscope
Study to assess the capability of physicians (breast surgeons and pathologists) to recognize breast cancer in images of fresh lumpectomies generated with the Histolog Scanner, a recent large field-of-view confocal laser scanning…
- Trial name
- Hibiscuss (NCT04976556)
- Testing
- Histolog Scanner
- Where
- France
- Volunteers
- 181 people
- Sponsor
- SamanTree Medical SA
Triple Negative Breast Cancer
A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer
This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in…
- Trial name
- NCT02032277
- Testing
- Cyclophosphamide, Doxorubicin, Paclitaxel
- Where
- 158 sites in United States, Australia and 13 more
- Volunteers
- 634 people
- Sponsor
- AbbVie
Triple Negative Breast Cancer
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC)…
- Trial name
- NCT05633654
- Testing
- Sacituzumab govitecan-hziy (SG), Pembrolizumab, Capecitabine
- Where
- 376 sites in United States, Australia and 10 more
- Volunteers
- 1,514 people
- Sponsor
- Gilead Sciences
Breast Cancer
Investigation of Novel Surgical Imaging for Tumor Excision
This is a multi-center, two-arm randomized, blinded pivotal study to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in…
- Trial name
- INSITE (NCT03686215)
- Testing
- Study Device Arm
- Where
- 14 sites in United States
- Volunteers
- 406 people
- Sponsor
- Lumicell, Inc.
Breast Neoplasms, Breast Cancer
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR) low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer.
- Trial name
- NCT06797635
- Testing
- Patritumab deruxtecan, Pembrolizumab, Paclitaxel
- Where
- 17 sites in United States, South Korea and 2 more
- Volunteers
- 372 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Cancer Female
Intraoperative Use of an Optical Coherence Tomography (OCT) Imaging System to Guide Additional Margin Cavity Shaves in Breast Conserving Surgery (BCS)
Female patients undergoing a breast conserving procedure will be consented for the excised breast tissue to be imaged on an investigational OCT-based device.
- Trial name
- NCT04314700
- Testing
- OCT- based investigational imaging device
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Perimeter Medical Imaging
Breast Neoplasms
Efficacy and Safety of Letrozole vs. Letrozole Plus Zoledronic Acid as Endocrine Therapy Before Surgery in Postmenopausal Patients With Breast Cancer
This study will evaluate the safety/efficacy of zoledronic acid when given by intravenous infusion every 4 weeks in addition to letrozole as endocrine therapy in postmenopausal patients with hormone responsive breast cancer
- Trial name
- FEMZONE (NCT00375752)
- Testing
- Letrozole, Zolendronic Acid
- Where
- 27 sites in Germany
- Volunteers
- 168 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Ph II Early BC Pre-Surgical Biologic Study
A pre-surgery study to assess changes that occur in human breast cancer material and normal skin after a short course of treatment with Iressa.
- Trial name
- NCT00637026
- Testing
- Gefitinib
- Volunteers
- 65 people
- Sponsor
- AstraZeneca
Breast Cancer
Improving Surgical/Medical Oncology Collaboration for Breast Cancer Treatment Planning: Pilot Testing the Impact of Continuing Education and Patient Care Planning
This study will explore provider's screening and management practices for eligibility for neoadjuvant therapy from baseline to following the project intervention (use of a novel existing technology, the Carevive Care Planning…
- Trial name
- NCT03161600
- Testing
- Carevive CPS
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Carevive Systems, Inc.
Breast Cancer
SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery
This is a multicenter, first-in-human (FIH), open label, Phase 1 dose escalation and recommended Phase 2 dose (RP2D) extension trial with a primary objective to define the RP2D of SRG-514 when administered intraoperatively to…
- Trial name
- NCT06300411
- Testing
- SRG-514
- Where
- 8 sites in United States
- Volunteers
- 25 people
- Sponsor
- SURGE Therapeutics
Breast Neoplasm Female, Breast Cancer
Fluorescence Imaging of Carcinoma During Breast Conserving Surgery
Breast conserving surgery (BCS) is performed on patients with breast cancer to resect and completely remove the cancer while conserving as much of the surrounding healthy tissue as possible.
- Trial name
- NCT04815083
- Testing
- Aminolevulinic Acid Hydrochloride, Eagle V1.2 Imaging System
- Where
- 7 sites in United States
- Volunteers
- 57 people
- Sponsor
- SBI ALApharma Canada, Inc.
Breast Cancer
A Study of ZD1839 Effects on Cell Proliferation in Breast Cancer
This is a Phase II, randomised, double-blind, placebo-controlled study. Subjects with histologically-confirmed oestrogen receptor negative (ER-), progesterone receptor negative (PgR-) primary breast cancer breast cancer will be…
- Trial name
- NCT00252811
- Testing
- Gefitinib
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- AstraZeneca
HER2-positive Breast Cancer, Early-stage Breast Cancer
Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03
This is an extension study to provide adjuvant treatment with single agent Herceptin or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following neoadjuvant treatment and…
- Conditions
- HER2-positive Breast Cancer, Early-stage Breast Cancer, Breast Cancer, Breast Neoplasms
- Trial name
- NCT04109391
- Testing
- TX05 (trastuzumab), Herceptin (trastuzumab)
- Where
- 86 sites in Belarus, Chile and 8 more
- Volunteers
- 338 people
- Sponsor
- Tanvex BioPharma USA, Inc.