300 Participants Needed

Systemic Therapy for Breast Cancer

Recruiting at 1 trial location
RA
TG
Overseen ByTracey Guthrie
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study genetic changes in tumor cells before and after chemotherapy in breast cancer patients. Researchers seek to understand how these cells react to treatments administered before or after surgery, known as neoadjuvant or adjuvant systemic therapy, respectively. Participants will provide tissue, blood, and possibly bone marrow samples during their treatment. The trial seeks individuals recently diagnosed with stage II, III, or IV breast cancer who plan to undergo or have completed chemotherapy. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in breast cancer therapy.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that treatments given before or after breast cancer surgery are usually well-tolerated. Studies have found that these treatments can lower death rates and extend patients' lives. While side effects can occur, most people manage them well. These treatments are commonly used for early-stage breast cancer, providing extensive information on their safety for humans. For those considering joining this trial, current evidence suggests that the treatments are safe for most people. Always discuss any concerns with a doctor.12345

Why are researchers excited about this trial?

Researchers are excited about the trial for neoadjuvant or adjuvant systemic therapy in breast cancer because it explores how these therapies impact cancer cells in different parts of the body, like bone marrow and circulating cancer cells. Unlike standard treatments that primarily focus on shrinking tumors, this approach also collects tissue, blood, and bone marrow samples at various stages, which can help understand the effect of therapy on cancer spread. This comprehensive examination might reveal new insights into how systemic therapies can be tailored to prevent metastasis and improve outcomes for patients.

What evidence suggests that this trial's treatments could be effective?

This trial will collect tissue, blood, and bone marrow samples and administer neoadjuvant or adjuvant systemic therapy. Studies have shown that treatments given before or after surgery effectively treat breast cancer. Neoadjuvant therapy, administered before surgery, can shrink tumors, making them easier to remove. Adjuvant therapy, given after surgery, helps destroy any remaining cancer cells and lowers the risk of recurrence. Research indicates that both methods significantly improve survival rates and reduce the chance of cancer spreading to other parts of the body. Overall, these treatments have successfully reduced death rates among breast cancer patients.56789

Who Is on the Research Team?

RA

Rebecca Aft, M.D., Ph.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

Recently diagnosed with clinical stage II, III, or IV breast cancer
Planning to undergo neoadjuvant or adjuvant systemic therapy; patients who have already completed neoadjuvant systemic therapy are also eligible
If female, must not be pregnant
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Systemic Therapy

Participants undergo neoadjuvant systemic therapy, including initial surgery for sentinel lymph node biopsy/portacath placement and definitive cancer surgery if applicable

Varies

Adjuvant Systemic Therapy

Participants undergo adjuvant systemic therapy, including initial surgery for sentinel lymph node biopsy/portacath placement and portacath removal after 1 year if available

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment, with sample collection if metastatic disease develops

Varies

What Are the Treatments Tested in This Trial?

Interventions

  • Bone marrow biopsy
  • Breast tissue collection
  • Neoadjuvant or Adjuvant Systemic Therapy
  • Peripheral blood draw

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Tissue, blood, and bone marrow (optional) collectionExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Citations

Long-term outcomes for neoadjuvant versus adjuvant ...

NACT is as effective as adjuvant chemotherapy in reducing the risk of distant recurrence and death from breast cancer. However, NACT is associated with higher ...

Impact of neoadjuvant and adjuvant chemotherapy on ...

A recent study further indicated that a delay in surgery following NACT chemotherapy was correlated with inferior survival outcomes.

Adjuvant and Neoadjuvant Therapy for Breast Cancer

Chemotherapy, both neoadjuvant and adjuvant, has effectively reduced mortality rates and improved survival outcomes. Significant improvement in OS was observed ...

Neoadjuvant Versus Adjuvant Systemic Treatment in Breast ...

Conclusions: Neoadjuvant therapy was apparently equivalent to adjuvant therapy in terms of survival and overall disease progression. Neoadjuvant therapy, ...

The neoadjuvant approach to treatment of breast cancer

In this review we discuss contemporary neoadjuvant therapy approaches, with a focus on the interplay between imaging, systemic therapy, radiotherapy, and ...

Adjuvant and Neoadjuvant Therapy for Breast Cancer

We present a systematic review of the data required to estimate the proportional benefits and risks of modern adjuvant and neoadjuvant treatment ...

Real-world survival outcomes of neoadjuvant versus ...

Real-world survival outcomes of neoadjuvant versus adjuvant chemotherapy in operable triple-negative breast cancer: a propensity score matched ...

Adjuvant systemic therapy in early breast cancer and ...

Primary endpoints of the BRIDE study were: percentage of patients with a stage I-II-III breast cancer eligible to initiate a neoadjuvant ...

Systemic Therapy in Breast Cancer

Neoadjuvant systemic therapy is commonly used for early-stage breast cancer. Clinicians must understand the indications and appropriate use of contemporary ...

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