Trastuzumab for Carcinoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Sainte Genevieve County Memorial Hospital, Sainte Genevieve, MO
Carcinoma+9 More
Trastuzumab - Biological
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This study is evaluating whether a combination of chemotherapy, radiation therapy, and hormone therapy is more effective than chemotherapy, radiation therapy, and hormone therapy alone in treating patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-

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Eligible Conditions

  • Carcinoma
  • Stage IIA Breast Cancer AJCC v6 and v7
  • Stage IIIB Breast Cancer AJCC v7
  • Stage IIIA Breast Cancer AJCC v7
  • Stage IIB Breast Cancer AJCC v6 and v7
  • Hormone Receptor-Positive Breast Carcinoma
  • Stage IIIC Breast Cancer AJCC v7
  • HER2-Positive Breast Carcinoma
  • Stage IB Breast Cancer AJCC v7

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

This trial is evaluating whether Trastuzumab will improve 1 primary outcome and 12 secondary outcomes in patients with Carcinoma. Measurement will happen over the course of Baseline to up to 6 weeks after last dose of chemotherapy.

Week 4
Change in QOL as measured by the Functional Assessment of Cancer Therapy-Breast Trial Outcome Index (FACT-B TOI) and the 12-item Short Form (SF-12) Physical Component Scale (PCS)
Week 4
Change in endocrine-related symptoms using Breast Cancer Prevention Trial (BCPT) symptom checklist
Week 6
Change in greater vasomotor symptoms, musculoskeletal complaints, and vaginal problems, as measured by the subscale scores from the BCPT symptom checklist
Year 5
Rate of second primary invasive cancer of any type
Year 4
OS
Year 4
RFI
Up to 3.9 years
Levels of tumor-infiltrating lymphocytes
Patterns of pCR by menopausal status
Rate of pCR in the breast
Rate of pCR in the breast and post therapy lymph nodes
Up to 5 years
Patterns of OS by menopausal status
Patterns of RFI by menopausal status
Week 6
Incidence of cardiac toxicity categorized according to National Cancer Institute CTCAE version 4.0

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Arm I (combination chemotherapy, surgery, radiation)
1 of 2
Arm II (chemo, estrogen deprivation, surgery, radiation)
1 of 2
Active Control
Experimental Treatment

This trial requires 315 total participants across 2 different treatment groups

This trial involves 2 different treatments. Trastuzumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Arm II (chemo, estrogen deprivation, surgery, radiation)NEOADJUVANT: All patients receive docetaxel, carboplatin, trastuzumab, and pertuzumab as in arm I. Premenopausal patients also receive goserelin acetate SC every 28 days until surgery and aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Postmenopausal patients receive aromatase inhibition therapy at the investigator's discretion daily until 1 day before surgery. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment. SURGERY: Patients undergo lumpectomy or mastectomy. RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery. ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
Arm I (combination chemotherapy, surgery, radiation)NEOADJUVANT: Patients receive docetaxel IV over 60 minutes, carboplatin IV over 30-60 minutes, trastuzumab IV over 30-90 minutes, and pertuzumab IV over 30-60 on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients enrolled after Amendment #4 undergo 2 core biopsies prior to course 3 of treatment. SURGERY: Patients undergo lumpectomy or mastectomy. RADIATION: Patients undergo whole breast irradiation within 8 weeks following surgery. ADJUVANT: Patients receive trastuzumab IV over 30-60 minutes every 21 days for up to 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
FDA approved
Pertuzumab
FDA approved
Aromatase Inhibition Therapy
2011
Completed Phase 3
~3500
Docetaxel
FDA approved
Therapeutic Conventional Surgery
2014
Completed Phase 3
~8360
Carboplatin
FDA approved
Whole Breast Irradiation
2017
N/A
~160
Goserelin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: time from randomization until death from any cause, assessed up to 8.4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly time from randomization until death from any cause, assessed up to 8.4 years for reporting.

Closest Location

Sainte Genevieve County Memorial Hospital - Sainte Genevieve, MO

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
As a general rule, patients diagnosed with breast cancer should have a life expectancy of at least 10 years, barring any other comorbid health conditions show original
Release of tumor samples from the local pathology department is required for all patients; the department's policy on release of samples for research purposes must be considered in the screening process; patients whose tumor samples are not available for research purposes should not be approached for participation in the B-52 trial. show original
Women of reproductive potential must agree to use an effective non-hormonal method of contraception during study therapy (chemotherapy, trastuzumab, pertuzumab, and estrogen deprivation therapy) and for at least 7 months after the last dose of study therapy
The patient must have agreed to participate in the study by signing an IRB-approved consent form show original
The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Clinical staging for the primary tumor can be cT1c (must be 2.0 cm) or T2-T4 if clinically node negative; if the regional lymph nodes are cN1 and cytologically or histologically positive or if cN2-N3 with or without a biopsy, the primary breast tumor can be cT0-T4
The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy
Nodal status - negative
Imaging of the axilla is negative
Imaging is suspicious or abnormal but the FNA or core biopsy of the questionable node(s) on imaging is negative

Patient Q&A Section

What are common treatments for breast cancer?

"Breast cancer is rarely treated through the "traditional" approach of surgery, radiation and/or chemotherapy, rather being addressed through a variety of approaches that are largely based upon patient characteristics and the stage of the tumour (ie. luminal B/triple negative). Most treatment is multidisciplinary and requires an effective team-based approach." - Anonymous Online Contributor

Unverified Answer

How many people get breast cancer a year in the United States?

"Only 1 in 20 women developed breast cancer. The lifetime risk of invasive breast cancer is estimated at only 2%. Breast cancer prevention with screening should be provided on a population basis to all women, men and those at high risk, rather than a small percentage of those most likely to develop the disease." - Anonymous Online Contributor

Unverified Answer

Can breast cancer be cured?

"The incidence of breast cancer is significantly lowered after surgery and/or radiation treatment. Thus, the risk of death from breast cancer is low compared with mortality in the general population. It is possible that cure of breast cancer is rare because only about 5% of patients are cured, mostly in early stages." - Anonymous Online Contributor

Unverified Answer

What causes breast cancer?

"Obesity has been linked to increased [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) risk due to an increase in circulating estrogen levels. Smoking is the most widely accepted cause of breast cancer, though there is a growing body of evidence that other agents, including exposure to endocrine disruptors and some toxins, may increase breast cancer risk, and some may lower breast cancer risk. While it appears to be more strongly associated with estrogen-dependent cancers such as breast cancer than are vitamins and minerals, none of the dietary factors is thought to be either primary or exclusive. The reasons for the possible beneficial effects of certain foods and beverages on breast cancer risk are not yet fully understood." - Anonymous Online Contributor

Unverified Answer

What are the signs of breast cancer?

"In women in their 50s and early 60s, signs of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) including nipple discharge and/or lump in the breast. A low-grade breast cancer can present as nipple discharge without lumping, usually with no pain; in women in their 60s and elderly, breast cancer can present with a lump that sometimes feels like a lumps in the breast. In women in their 50s and early 60s, it is advisable to receive a mammogram every one-to-two years to make sure you are staying healthy and avoiding getting breast cancer. In women in their 60s and older, your mammogram would likely make the correct diagnosis even without the lump feeling firm or hard." - Anonymous Online Contributor

Unverified Answer

What is breast cancer?

"Breast cancer is by far the most common type of cancer in women in the USA. Nearly one third of women will be diagnosed with breast cancer before their 70th birthday." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of breast cancer?

"My conclusion has consistently been that it is not likely that exposure to cellular phones, electric power lines or other sources is a cause of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). The vast majority of breast cancer cases are not related to these sources. I have never witnessed an actual case of a man getting a breast cancer and his primary is not cellphone use. I also cannot remember hearing about a woman who got breast cancer and her primary is not a cellphone. The reason is understandable and is that a breast carcinoma is a very slow growing cancer (like most other cancers, some are not even diagnosed until they have progressed so much that they have become almost cancerous)." - Anonymous Online Contributor

Unverified Answer

What is the latest research for breast cancer?

"The present study highlights the need for prospective and multidisciplinary studies of breast cancer, as well as the importance of developing appropriate research strategies for identifying important research questions to determine best practice and most effective breast cancer treatment approaches." - Anonymous Online Contributor

Unverified Answer

How serious can breast cancer be?

"The vast majority of women who are diagnosed with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) live for more than 10 years and are still alive and disease free at the time of diagnosis. Many who suffer breast cancer do not have any symptoms before a diagnosis is made, while others experience symptoms such as unexplained weight loss, unexplained malaise, or a lump in the breast. A diagnosis of breast cancer is an important event as it alters attitudes toward the disease and how it is treated. Further research is needed to enhance understanding about the risks of breast cancer, as well as ways to improve communication about risks from screening, diagnosis, and treatment." - Anonymous Online Contributor

Unverified Answer

What does pertuzumab usually treat?

"If we exclude chemotherapy and hormonal therapy as well as surgery, for example, with or without radiotherapy, then we can conclude that the pertuzumab-therapy should not be included in the treatment of patients with HER2-positive breast cancer who can receive adjuvant chemotherapy, with regard to the PFS and OS, because the PFS and OS of the patients do not show any significant difference compared to that of patients without chemotherapy but was reported in previous reports." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating breast cancer?

"Even though there has not been any conclusive evidence regarding treatment for breast cancer, new therapies do seem to be emerging. With proper research on how breast cancer cells are affected with the treatments, there is always a chance that a breakthrough in breast cancer treatment will be made. These new treatments for breast cancer, such as anti-angiogenic agents or targeted therapies such as human epidermal growth factor receptor 2 (HER2/neu) may also be helpful to patients who are diagnosed with breast cancer as well as their families." - Anonymous Online Contributor

Unverified Answer

Has pertuzumab proven to be more effective than a placebo?

"When patients are treated with Pertuzumab before surgery for operable breast cancer and are followed up for an average of 15 months, no new evidence of disease seems to arise. As such, Pertuzumab cannot be considered an effective and safe treatment for patients undergoing surgery for operable breast cancer because of the lack of a long-term follow up." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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