Clinical Trials Logo
  1. Home
  2. HER2-negative Breast Cancer
  3. NCT05503108

Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in Hormone Receptor Postive (HR+), HER2- Breast Cancer — DIRECT-2  

HER2-negative Breast Cancer Clinical Trial

Official title:
DIRECT-2: Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in HR+, HER2- Breast Cancer

Clinical Trial Summary

In preclinical research, short-term fasting (STF) protects tumor-bearing mice against the toxic effects of chemotherapy, improves the CD8+ effector T-cell intratumor infiltration, while enhancing the chemotherapy efficacy. Short-term use of a "fasting-mimicking diet" (FMD) caused a major increase in the efficacy of cancer treatment in mice comparable to STF. In humans, the investigators recently performed a multicenter randomized phase II trial showing that patients with Human Epidermal growth factor Receptor 2 (HER2) negative breast cancer treated with neoadjuvant chemotherapy and FMD displayed a better radiological response and a better pathological response (90-100% vs <90% tumor cell reduction) than patients treated with chemotherapy without FMD (de Groot, Nat Commun 2020; NCT02126449). Therefore these findings will be validated in a phase 3 trial with the underlying hypothesis that FMD during neoadjuvant chemotherapy for breast cancer improves clinical outcomes, potentially due to improved local immunity.

Clinical Trial Description

STF during neadjuvant chemotherapy aiming to improve the chemotherapy efficacy and decline the side effects in patients with stage II-III HR+, HER2- breast cancer ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05503108
Study type Interventional
Source Leiden University Medical Center
Contact
Status Suspended
Phase Phase 3
Start date March 17, 2023
Completion date January 1, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05383196 - Onvansertib + Paclitaxel In TNBC Phase 1/Phase 2
Completed NCT02371174 - Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan.
Completed NCT02225470 - Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes Phase 3
Recruiting NCT05173103 - Retrospective Study of 2nd-line Therapies After CDK4/6i + Hormonal Therapy in HR+/HER2- Advanced Breast Cancer
Active, not recruiting NCT04448886 - Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC Phase 2
Not yet recruiting NCT04498793 - Study of Tislelizumab Plus Chemotherapy vs Chemotherapy as Perioperative Treatment in Participants With HER2 Negative Breast Cancer Phase 2
Completed NCT01705691 - Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer Phase 2
Terminated NCT01368263 - Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer Phase 2
Recruiting NCT04576143 - Efficacy and Safety of Dose-dense Chemotherapy (ddEC-ddP) for Neoadjuvant Chemotherapy of HER2-negative Breast Cancer Phase 2/Phase 3
Completed NCT05054374 - A Study of Mirdametinib on Its Own or in Combination With Fulvestrant in People With Solid Tumor Cancer Phase 1/Phase 2
Recruiting NCT05467891 - Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer Phase 2
Recruiting NCT04660435 - To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer
Completed NCT02015559 - Mucoadhesive Oral Wound Rinse in Preventing and Treating Stomatitis in Patients With ER- or PR-Positive Metastatic or Locally Recurrent Breast Cancer That Cannot be Removed by Surgery Receiving Everolimus Phase 2
Completed NCT04504916 - A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Solid Tumors (MK-2140-002) Phase 2
Terminated NCT04738292 - Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study) Phase 2
Recruiting NCT05982093 - Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer Phase 2
Recruiting NCT05396612 - Role of the Immune Environment in Response to Therapy in Breast Cancer
Active, not recruiting NCT04595565 - Sacituzumab Govitecan in Primary HER2-negative Breast Cancer Phase 3
Terminated NCT01234532 - Entinostat and Anastrozole in Treating Postmenopausal Women With TNBC That Can Be Removed by Surgery Phase 2
Terminated NCT01217411 - RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer Phase 1