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GUAIACOL

Clinical trials investigating GUAIACOL are evaluating treatment strategies in people with breast cancer, especially triple negative breast cancer and hormone receptor-low positive/HER2 negative breast cancer. These studies are looking at how well the tested treatments work before surgery and how they affect survival outcomes.

Table of Contents

Trial overview

The available clinical trial for GUAIACOL is an interventional study, which means the researchers assign treatment plans to the people in the study.[1] It is focused on breast cancer and is currently listed as Authorised.[1]

The study title describes it as a clinical study of sac-TMT in people with breast cancer (MK-2870-032).[1] The trial compares treatment strategies that include GUAIACOL-related study treatment and other cancer medicines used in breast cancer care.[1]

Who the trial is for

This study is for people with breast cancer, especially those with triple negative breast cancer (TNBC) and hormone receptor-low positive/HER2 negative breast cancer.[1] These are specific breast cancer groups, and the trial is designed to see how well the study treatments work in these patients.[1]

The trial summary does not list every entry rule, but it clearly shows the target population is people with these breast cancer types.[1]

What is being tested

The trial compares sac-TMT followed by carboplatin/paclitaxel versus chemotherapy, and both study approaches are combined with pembrolizumab as neoadjuvant therapy.[1] Neoadjuvant therapy means treatment given before surgery.[1]

The brief summary also mentions pembrolizumab with optional adjuvant TPC in one of the compared strategies.[1] Adjuvant treatment means treatment given after the main treatment, often after surgery, to help reduce the chance of cancer returning.[1]

Other medicines listed in the trial record include capecitabine, cyclophosphamide, paclitaxel, dexamethasone, doxorubicin, epirubicin, carboplatin, and KEYTRUDA.[1] These are part of the treatment options being studied in this breast cancer trial.[1]

Study phase and design

The trial is in Phase 3, which is a later stage of research that usually compares treatment plans in a large number of people.[1] The enrollment is listed as 2645 participants, showing that this is a large study.[1]

Because it is an interventional trial, the study is not just observing what happens naturally. Instead, it gives assigned treatment plans so researchers can compare outcomes between groups.[1]

Main outcomes

The first main outcome is pathological complete response (pCR), using the definition ypT0/Tis ypN0.[1] This means that after treatment and surgery, the pathologist checks the removed tissue for signs of invasive cancer.[1]

The second main outcome is event-free survival (EFS).[1] This measures how long participants stay free from cancer-related events, and it is assessed by the investigator in all participants.[1]

The trial summary says the study is comparing treatment plans first by pCR at the time of surgery and then by EFS over time.[1] These outcomes help show both short-term treatment response and longer-term disease control.[1]

What the study means for patients

For patients, this trial is trying to find out which treatment plan works better before surgery for certain breast cancer types.[1] It focuses on whether the cancer disappears from the breast and lymph nodes at surgery and whether people stay free from cancer-related events afterward.[1]

The study is important because it is testing treatment strategies in a large Phase 3 group, which can help answer practical questions about cancer care in these breast cancer subtypes.[1]

Trial ID Phase Condition studied Status Enrollment
2024-520190-12-00 Phase 3 Breast cancer, including TNBC and HR-low positive/HER2 negative breast cancer Authorised 2645

FAQ

  • What are the GUAIACOL clinical trials studying? The trial data describe a Phase 3 study in breast cancer. It compares treatment approaches given before surgery and measures how well they work.
  • Who can take part in these trials? The study is for people with breast cancer, including triple negative breast cancer and hormone receptor-low positive/HER2 negative breast cancer.
  • What phase is the GUAIACOL trial? The trial is in Phase 3. This means it is a later-stage study that compares treatments in a large group of people.
  • What results are the researchers measuring? The main results are pathological complete response, also called pCR, and event-free survival, also called EFS. pCR checks whether no invasive cancer is seen at surgery, and EFS checks how long people remain free from cancer-related events.
  • Is this a treatment study or an observation study? This is an interventional study, which means participants receive assigned treatments. The trial compares different treatment plans.

Ongoing Clinical Trials on GUAIACOL

  • Study of sacituzumab tirumotecan, pembrolizumab and chemotherapy combination for early-stage triple-negative breast cancer or hormone receptor-low positive/HER2-negative breast cancer

    Recruiting

    1 1 1 1
    Investigated drugs:
    Belgium Czechia Finland France Germany Greece +8

Glossary

  • Breast cancer: A cancer that starts in the breast tissue.
  • Triple negative breast cancer (TNBC): A breast cancer type that does not have estrogen receptors, progesterone receptors, or HER2.
  • Hormone receptor-low positive: A breast cancer type with only a small amount of hormone receptor expression.
  • HER2 negative: A cancer that does not have high levels of the HER2 protein.
  • Phase 3: A later stage of research that compares treatments in larger groups of people.
  • Interventional study: A study where researchers assign treatments to participants.
  • Neoadjuvant therapy: Treatment given before surgery.
  • Pathological complete response (pCR): A result showing no invasive cancer found in the tissue removed at surgery.
  • Event-free survival (EFS): The length of time after treatment during which a person does not have a cancer-related event.
  • Surgery: An operation to remove cancer or tissue.

References

  1. https://clinicaltrials.gov/study/2024-520190-12-00