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Metastatic Breast Cancer clinical trials

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NCT ID: NCT05955833 Recruiting - Breast Cancer Clinical Trials

89Zr-DFO*-Trastuzumab PET in Patients With Gastric or Breast Cancer - a Pilot Study

HER Image
Start date: June 26, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to test a new PET tracer in patients with HER2-positive breast or gastric cancer. This tracer is made of radioactively labeled trastuzumab, and can show where HER2 is present in the body using a PET-scan. For this research, the investigators make PET-scans in people with HER2-positive, metastasized breast- or gastric cancer. The investigators will investigate if the new HER2-tracer correctly shows all tumor lesions. In the future, this method may be useful to help predict who will benefit from certain HER2-directed therapies. Participants will be injected with the radioactive tracer once. After injection, participants will undergo 3 PET-scans. Each PET-scan will take a maximum of 60 minutes. The PET-scans are on separate days within a week after injection of the tracer (e.g. 1 day, 2 days and 4 days after injection). Furthermore, the investigators will take 7 blood samples (5 mL each). Participants are not required to stay at the hospital. The first 3 participants will undergo an extra PET-scan 1 - 2 hours after injection. The amount of radioactivity injected will be 37 MBq (± 10%).

NCT ID: NCT05954442 Recruiting - Clinical trials for Metastatic Breast Cancer

Everolimus With Investigator's Choice of Chemotherapy in Advanced Triple-Negative Breast Cancer (TNBC) With Luminal Androgen Receptor (LAR) Subtype

BCTOP-T-M03
Start date: September 13, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy of investigator's choice of chemotherapy, either alone or in combination with everolimus, in treating patients with locally recurrent inoperable or metastatic triple-negative breast cancer, luminal androgen receptor (LAR) subtype with PI3K/AKT/mTOR (PAM) pathway mutation, as the first-line treatment.

NCT ID: NCT05945732 Recruiting - Clinical trials for Metastatic Breast Cancer

DESTINY Breast Respond HER2-low Europe

Start date: October 24, 2023
Phase:
Study type: Observational

Trastuzumab deruxtecan (T-DXd) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

NCT ID: NCT05933876 Recruiting - Clinical trials for Metastatic Breast Cancer

The Impact of Radiotherapy on Oligometastatic Cancer

Start date: December 1, 2022
Phase:
Study type: Observational [Patient Registry]

Metastases represent the most threatening challenge in cancer. One of the management strategies for patients with Oligometastatic Cancer (OC) is Stereotactic ABlative Radiotherapy (SABR). However, there are few studies, and there is no defined clinical standard, nor are the radiobiological mechanisms that contribute to treatment response well understood. The focus should be on generating evidence to guide the personalization of radiotherapy beyond solely technological and anatomical precision. This could be achieved by recollecting clinical and biological data from patients that undergo this treatment and analyzing them to ultimately predict, with the help of artificial intelligence, which patients will be the most beneficiary and improve their survival rate.

NCT ID: NCT05927779 Recruiting - Clinical trials for Metastatic Breast Cancer

Study of TFX06 in Women With Advanced Breast Cancer.

Start date: April 17, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1/2 Dose Escalation and Expansion Study of TFX06 tablet Alone in Women with ER Positive, HER2 Negative Advanced Breast Cancer

NCT ID: NCT05919212 Recruiting - Clinical trials for Metastatic Breast Cancer

Trastuzumab Deruxtecan (T-DXd): Tailoring Treatment and Companion Diagnostics (CDx) by Liquid Biopsy

DIAMOND
Start date: February 1, 2023
Phase: N/A
Study type: Interventional

This is a prospective single-center pilot study phase II non randomized designed to explore the role of liquid biopsy in metastatic HER2-positive breast cancer patients treated with Trastuzumab deruxtecan (T-Dxd) as second line treatment according to international guidelines. All eligible patients to T-Dxd as second line treatment will receive T-Dxd intravenous at dose of 5,4 mg/kg every three weeks until progression disease or unacceptable toxicities. Subjects eligible to T-Dxd, who agree to participate in the study, will undergo serial blood samples for liquid biopsy (LB) until progression disease. The timing of blood drawing will be scheduled as follows: At each T-DXd administration for the first four cycles of T-Dxd (every three weeks). The next blood drawings will be done every three cycles of T-Dxd (every 9 weeks) until the thirteenth cycle. The next blood drawings will be done every six cycles of T-Dxd (every 18 weeks) until progression disease (documented by medical imaging) For all enrolled patients with available tumour tissue from primary diagnosis or last biopsy from recurrence, tissue samples will be requested for exploratory analysis.

NCT ID: NCT05907681 Recruiting - Breast Cancer Clinical Trials

Prospective Observational Study on Outcome of High-precision Hypo-fractionated Radiotherapy in Metastatic Breast Cancer (PRECISE-M)

Start date: May 11, 2023
Phase:
Study type: Observational [Patient Registry]

This study is a prospective observational study on outcomes of high precision hypo-fractionated radiotherapy in breast cancer with distant metastasis.

NCT ID: NCT05894239 Recruiting - Clinical trials for Metastatic Breast Cancer

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

Start date: July 28, 2023
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).

NCT ID: NCT05892068 Recruiting - Clinical trials for Metastatic Breast Cancer

A Study of Tucatinib Given Before Surgery to People With HER2+ Cancers That Have Spread to the Brain

Start date: May 9, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study to see how the brain absorbs, distributes, and gets rid of tucatinib in people who have HER2+ cancers (breast cancer, NSCLC, CRC, or GEC) that have spread to the brain, and to learn more about how cancer cells develop resistance to treatment. The researchers will do research tests to look for genetic differences between HER2+ breast cancer that has spread to the brain and progressed during treatment with tucatinib and cancers that are being treated with tucatinib for the first time.

NCT ID: NCT05868226 Recruiting - Solid Tumor Clinical Trials

PRE-I-SPY Phase I/Ib Oncology Platform Program

PRE-I-SPY-PI
Start date: December 22, 2022
Phase: Phase 1
Study type: Interventional

I-SPY Phase I/Ib (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and/or other oncology-based trials in a timely manner.