Systemic Therapy for Breast Cancer
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?
Rebecca Aft, M.D., Ph.D.
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Systemic Therapy
Participants undergo neoadjuvant systemic therapy, including initial surgery for sentinel lymph node biopsy/portacath placement and definitive cancer surgery if applicable
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
Follow-up
Participants are monitored for safety and effectiveness after treatment, with sample collection if metastatic disease develops
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?
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Treatment groups
Experimental Treatment
* Undergo neoadjuvant systemic therapy * initial surgery for sentinel lymph node biopsy/portacath placement * definitive cancer surgery (if applicable) * when portacath is removed (1 year, if available) * if metastatic disease develops or is present in accessible sites, a sample may be collected at the time of specimen collection for diagnosis * Undergo Adjuvant Systemic Therapy * initial surgery for a sentinel lymph node biopsy/portacath placement * when portacath is removed (1 year, if available) * If metastatic disease develops or is present in accessible sites, a sample may be collected at the time of specimen collection for diagnosis. * Undergone neoadjuvant systemic therapy * during definitive cancer surgery/portacath removal (if available) * if metastatic disease develops or is present in accessible sites, a sample may be collected at the time of specimen collection for diagnosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
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.
3.
eurjbreasthealth.com
eurjbreasthealth.com/articles/adjuvant-and-neoadjuvant-therapy-for-breast-cancer-a-systematic-review/ejbh.galenos.2024.2023-12-16Adjuvant 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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