100 Participants Needed

Angiomammography for Breast Cancer Response Prediction

Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: CHU de Quebec-Universite Laval
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Angiomammography for Breast Cancer Response Prediction?

The research suggests that neoadjuvant chemotherapy, which is part of the treatment, is becoming a standard approach for breast cancer and helps in avoiding more invasive surgeries. Imaging techniques, like those used in Angiomammography, are valuable for assessing how well the cancer responds to this chemotherapy, potentially allowing for more personalized and effective treatment plans.12345

How is neoadjuvant chemotherapy different from other breast cancer treatments?

Neoadjuvant chemotherapy is unique because it is given before surgery to shrink tumors, making them easier to remove and potentially allowing for less extensive surgery. It also helps doctors assess how the cancer responds to treatment, which can guide further therapy decisions.24678

What is the purpose of this trial?

The best prognostic factor following neoadjuvant chemotherapy is the pathological complete response (pCR). pCR is defined as the absence of invading cells in the breast and lymph nodes following neoadjuvant chemotherapy treatment. Since patients with pCR have a better prognosis than those without pCR, some studies have evaluated different methods to predict pCR early in treatment. Thus, patients who do not respond optimally to treatment could be identified early and changed treatment in order to maximize the chances of pCR and avoid the morbidity of poorly effective treatments. To do this, several modalities have been proposed, including MRI, mammography, ultrasound, positron emission tomography, elastography, and serial biopsies, but these techniques have shown predictive and sometimes expensive. Nevertheless, assessment of tumor response after cycle 2 has been suggested to be appropriate for the prediction of pCR.The main objective of this study is to compare the performance of two diagnostic modalities, namely CESM and MRI, in the evaluation of the response of a malignant breast tumor to neoadjuvant chemotherapy and the prediction of pCR. The radiological response will also be compared to the clinical response.

Eligibility Criteria

This trial is for women over 18 with breast cancer that hasn't spread far (no distant metastasis), measurable by examination. They must be undergoing neoadjuvant chemotherapy, possibly with additional targeted therapy. Exclusions include pregnancy, allergies to contrast dye, MRI contraindications, overt hyperthyroidism, and significant kidney failure.

Inclusion Criteria

I have received chemotherapy before surgery, with or without targeted therapy.
My cancer has not spread to distant parts of my body.
My breast cancer was confirmed with a biopsy.
See 2 more

Exclusion Criteria

I have severe kidney problems.
You have health conditions that make it unsafe for you to have an MRI scan.
Pregnant or possibly pregnant woman
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive neoadjuvant chemotherapy to evaluate the response of a malignant breast tumor

6 weeks
2 cycles of chemotherapy, each cycle being 21 days

Assessment

Prediction of pathological complete response (pCR) using angiomammography after cycle 2 of neoadjuvant chemotherapy

1 week
1 visit (in-person) for imaging assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Angiomammography
  • Neoadjuvant Chemotherapy
Trial Overview The study compares two imaging techniques—CESM and MRI—to see which better predicts the absence of invasive cancer cells in the breast and lymph nodes after early rounds of chemotherapy. This could help switch treatments sooner for those not responding well.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant chemotherapyExperimental Treatment1 Intervention

Neoadjuvant Chemotherapy is already approved in European Union, United States, Canada, Japan, China for the following indications:

🇪🇺
Approved in European Union as Neoadjuvant Chemotherapy for:
  • Breast cancer
  • Ovarian cancer
  • Colorectal cancer
  • Lung cancer
  • Esophageal cancer
🇺🇸
Approved in United States as Neoadjuvant Chemotherapy for:
  • Breast cancer
  • Ovarian cancer
  • Colorectal cancer
  • Lung cancer
  • Esophageal cancer
  • Stomach cancer
🇨🇦
Approved in Canada as Neoadjuvant Chemotherapy for:
  • Breast cancer
  • Ovarian cancer
  • Colorectal cancer
  • Lung cancer
  • Esophageal cancer
🇯🇵
Approved in Japan as Neoadjuvant Chemotherapy for:
  • Breast cancer
  • Ovarian cancer
  • Colorectal cancer
  • Lung cancer
  • Esophageal cancer
  • Stomach cancer
🇨🇳
Approved in China as Neoadjuvant Chemotherapy for:
  • Breast cancer
  • Ovarian cancer
  • Colorectal cancer
  • Lung cancer
  • Esophageal cancer
  • Stomach cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials
177
Recruited
110,000+

Findings from Research

Neoadjuvant chemotherapy is now a standard treatment for locally advanced breast cancer, but traditional imaging methods that focus on tumor size changes have limitations in accurately assessing treatment response.
Functional imaging technologies can provide a more comprehensive evaluation by detecting biological changes in tumors, predicting early responses to chemotherapy, and helping to tailor individualized treatment plans.
Multimodality Imaging for Evaluating Response to Neoadjuvant Chemotherapy in Breast Cancer.Rauch, GM., Adrada, BE., Kuerer, HM., et al.[2021]
Neoadjuvant chemotherapy for locally advanced breast cancer is increasingly common, and early imaging to assess treatment response could help determine if a switch to a more effective therapy is needed.
The cost-effectiveness analysis suggests that imaging systems are justified if they can demonstrate even a small increase in cure rates (as little as 1%) when switching from ineffective chemotherapy, especially if the initial treatment is less than 90% effective.
Prognostic imaging in neoadjuvant chemotherapy of locally-advanced breast cancer should be cost-effective.Schegerin, M., Tosteson, AN., Kaufman, PA., et al.[2021]
Neoadjuvant chemotherapy is now a standard treatment for larger breast tumors, allowing more patients to undergo breast-conserving surgery instead of mastectomy.
Factors such as histological grade, HER-2 status, p53, and hormone receptor status are important predictors of a favorable response to neoadjuvant chemotherapy, which is associated with better treatment outcomes.
[Option of the surgical mode for breast cancer based on the effect of neoadjuvant chemotherapy].Fukutomi, T.[2011]

References

Multimodality Imaging for Evaluating Response to Neoadjuvant Chemotherapy in Breast Cancer. [2021]
Prognostic imaging in neoadjuvant chemotherapy of locally-advanced breast cancer should be cost-effective. [2021]
[Option of the surgical mode for breast cancer based on the effect of neoadjuvant chemotherapy]. [2011]
[Evaluation of response to neoadjuvant chemotherapy using breast scintigraphy in breast cancer]. [2019]
[Therapy monitoring of neoadjuvant therapy with MRI. RECIST and functional imaging]. [2021]
Single static view 99mTc-sestamibi scintimammography predicts response to neoadjuvant chemotherapy and is related to MDR expression. [2018]
Predicting axillary response to neoadjuvant chemotherapy: the role of diffusion weighted imaging. [2023]
Comparative study of pathological response evaluation systems after neoadjuvant chemotherapy for breast cancer: developing predictive models of multimodal ultrasound features including shear wave elastography combined with puncture pathology. [2023]
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