Angiomammography for Breast Cancer Response Prediction

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: CHU de Quebec-Universite Laval

Disqualifiers: Pregnancy, Kidney failure, Hyperthyroidism, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

100 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Neoadjuvant chemotherapy Experimental Treatment 1 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

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Option of the surgical mode for breast cancer based on the effect of neoadjuvant chemotherapy]. Fukutomi, T.[2011]

In a study of 50 patients with stages II and III breast cancer, traditional methods like physical examination and mammography were found to be more effective than Tc-99m-sestamibi scintigraphy in predicting the response to neoadjuvant chemotherapy, with sensitivities of 86.5% and 83.3% respectively.

The study concluded that Tc-99m-sestamibi scintigraphy does not provide useful predictive information regarding chemotherapy response, as there were no significant correlations found between isotope uptake, clearance, and markers of chemo-resistance or tumor angiogenesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of response to neoadjuvant chemotherapy using breast scintigraphy in breast cancer]. Baena-Cañada, JM., Partida-Palma, F., Palomo-González, MJ., et al.[2019]

Neoadjuvant chemotherapy is becoming more common for operable breast cancer, and early prediction of treatment response is crucial for patient care.

Functional MRI shows promise in monitoring therapy response by assessing both tumor size and functional parameters, but more research is needed to fully evaluate its effectiveness compared to standard methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapy monitoring of neoadjuvant therapy with MRI. RECIST and functional imaging]. Grandl, S., Ingrisch, M., Hellerhoff, K.[2021]

A pre-treatment 99mTc-sestamibi scintimammography can effectively predict the response to neoadjuvant chemotherapy in invasive breast cancer, showing a significant correlation with tumor size reduction and pathological response.

The study found that a negative result from the scintimammography test indicated a 100% specificity for chemoresistance, meaning it reliably identified patients who would not respond well to chemotherapy, particularly in relation to the expression of the MDR1 protein.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single static view 99mTc-sestamibi scintimammography predicts response to neoadjuvant chemotherapy and is related to MDR expression. Cayre, A., Cachin, F., Maublant, J., et al.[2018]

In a study of 74 breast cancer patients undergoing neoadjuvant chemotherapy (NAC), an increase in the apparent diffusion coefficient (ADC) values of the primary tumor was found to correlate with a higher likelihood of achieving axillary complete response, with 42.8% of patients showing this response when ADC values increased above a specific threshold.

The study identified that axillary complete response was also associated with negative estrogen receptor status and Her2 positivity, suggesting that diffusion-weighted imaging could enhance predictive models for treatment outcomes in breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting axillary response to neoadjuvant chemotherapy: the role of diffusion weighted imaging. Graña-López, L., Pérez-Ramos, T., Maciñeira, FA., et al.[2023]

A predictive preoperative nomogram was developed using ultrasound characteristics and biopsy results from 145 breast cancer patients, which can effectively assess the pathologic response to neoadjuvant chemotherapy (NAC).

The nomogram demonstrated strong predictive accuracy with an area under the curve of 0.855 for pathologic complete response, indicating its potential to guide personalized treatment strategies for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Duan, Y., Song, X., Guan, L., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Multimodality Imaging for Evaluating Response to Neoadjuvant Chemotherapy in Breast Cancer. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Prognostic imaging in neoadjuvant chemotherapy of locally-advanced breast cancer should be cost-effective. [2021]

3. Japan pubmed.ncbi.nlm.nih.gov

[Option of the surgical mode for breast cancer based on the effect of neoadjuvant chemotherapy]. [2011]

4. Spain pubmed.ncbi.nlm.nih.gov

[Evaluation of response to neoadjuvant chemotherapy using breast scintigraphy in breast cancer]. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

[Therapy monitoring of neoadjuvant therapy with MRI. RECIST and functional imaging]. [2021]

6. Greece pubmed.ncbi.nlm.nih.gov

Single static view 99mTc-sestamibi scintimammography predicts response to neoadjuvant chemotherapy and is related to MDR expression. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Predicting axillary response to neoadjuvant chemotherapy: the role of diffusion weighted imaging. [2023]

8. China pubmed.ncbi.nlm.nih.gov

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]