pertuzumab for Breast Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
City of Hope Medical Center, Duarte, CA
Breast Cancer+11 More
pertuzumab - Biological
Eligibility
18+
Female
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether a combination of three drugs might be more effective than one drug alone in treating patients with HER2-positive stage II-IV breast cancer.

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Eligible Conditions

  • Breast Cancer
  • Breast Neoplasms
  • Inflammatory Breast Neoplasms
  • Stage IIB Breast Cancer
  • Stage IIA Breast Cancer
  • Breast Cancer, Stage IIIB
  • Recurrent Breast Cancer
  • HER2-positive Breast Cancer
  • Stage IIIA Breast Cancer
  • Breast Adenocarcinoma
  • Breast Cancer Stage IIIc
  • Carcinoma Breast Stage IV
  • Inflammatory Breast Carcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether pertuzumab will improve 3 primary outcomes and 6 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Up to 18 weeks (time of definitive surgery).

Year 5
Overall survival
Year 5
PFS (LABC patients)
PFS (MBC patients)
Progression free survival
Week 18
Complete pathologic response, analyzed using residual cancer burden score (LABC patients)
Day 30
Number of patients experiencing serious adverse events (AEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Up to 5 years
Clinical benefit rate, defined as the rate of complete response (CR) plus partial response (PR) plus stable disease (SD) (MBC patients)
Objective response rate (RECIST 1.1) (MBC patients)
Relapse-free survival (LABC patients)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Treatment (pertuzumab, trastuzumab, nab-paclitaxel)

This trial requires 65 total participants across 2 different treatment groups

This trial involves 2 different treatments. Pertuzumab 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 2 and have already been tested with other people.

Treatment (pertuzumab, trastuzumab, nab-paclitaxel)Patients receive pertuzumab IV over 30-60 minutes on day 1, trastuzumab IV over 30-90 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pertuzumab
FDA approved
Paclitaxel
FDA approved
Trastuzumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

City of Hope Medical Center - Duarte, CA

Eligibility Criteria

This trial is for female patients aged 18 and older. You must have received newly diagnosed for Breast Cancer or one of the other 11 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient's left ventricular ejection fraction must be greater than or equal to 50% (determined by echocardiogram or multigated acquisition scan) within 42 days of treatment. show original
Hemoglobin >= 9 g/dl
A person's leukocyte count is 3.0 x 10^9/L or higher. show original
If you have LABC, you are not allowed to have any prior therapy. show original
The patients must have been diagnosed with metastatic cancer that started in the breast, and must have either an over-expression of HER2, or cancer that has progressed to stage II-III after being newly diagnosed show original
The women of child-bearing potential and men in the study must agree to use contraception (hormonal or barrier method) prior to the start of the study and for six months following the study show original
(67% mantle cell lymphoma [MCL], 36% other B-cell lymphomas) Tumor expressing hormone receptors either below or above the 1% marker, and also overexpressing the HER2 gene by at least 3 intensity levels as determined by immunohistochemistry, or identified as being HER2 amplified by fluorescence in situ hybridization or another gene testing method, with the majority of cases being mantle cell lymphomas. show original
For patients who have MBC, they are allowed to have had prior adjuvant chemotherapy and trastuzumab more than or equal to 12 months prior to enrollment. show original
No prior chemotherapy or trastuzumab was administered to the patient for the treatment of metastatic breast cancer. show original
This text is talking about the "Eastern Cooperative Oncology Group" and how their "performance status" is either "0" or "1". show original

Patient Q&A Section

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

What are the signs of breast cancer?

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The physical signs of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) could be localized or systemic. The presence of a mass suggests local cancer involvement. Breast cancer can be associated with malaise, anorexia, weight loss, nipple deformity, and a new malaise. More alarming signs of systemic cancer involvement include a palpable mass, lymphedema, skin atrophy, and hepatomegaly.

Unverified Answer

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

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The American Cancer Society predicts that 1 in 2 American women will be diagnosed with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). Additionally, the American Cancer Society estimates approximately 300 new diagnoses of breast cancer will be made in 2012.\n

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Can breast cancer be cured?

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The cure rate for breast cancer remains very low (28) for women without node metastases. The cure rate is about 45% for women with node metastases. The use of tamoxifen decreases the possibility of recurrence in a large group of women with node metastases and tamoxifen may help these women have fewer recurrences.

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What is breast cancer?

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There is a high level of racial variance in the distribution of breast cancer incidence in the USA, with Hispanics having the highest rates, and this is due to different disease stage at diagnosis.

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What are common treatments for breast cancer?

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A number of medications are used for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), including: hormone therapy, chemotherapy, radiotherapy, and trastuzumab. The best treatment depends on the size of the tumor, overall condition, and general health of the patient. It is important to take into consideration that patients may benefit from psychological therapies and that they also need information about the treatment in order to take full advantage of it. Cancer can have a profound effect on patients and their families' lives. It is important that patients need to know that their cancer is being treated and what treatment is going to be provided in the future while still looking forward to recovery.

Unverified Answer

What causes breast cancer?

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There are many factors at the cellular level that confer a greater likelihood for cells in the mammary glands to develop [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). They include altered gene expression, mutated oncogenes and loss of tumor-suppressor genes, including the p53 gene. Although smoking is well established as being responsible for several types of cancers, we currently lack sufficient data to establish whether this is also the case for breast cancer. Clearly, more research is required to adequately confirm its association with breast cancer. However, it is also clear that a large percentage of breast cancer cases may be prevented by eliminating breast cancer risk factors.

Unverified Answer

What are the common side effects of pertuzumab?

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Pertuzumab has the most frequent side effects (in more than 80% of patients) of all agents, although more common with higher doses, and these effects are manageable with appropriate medication. The most common in women with HER-2/neu-overexpressing breast cancer in Phase II and III clinical trials were the following:\n- Anemia (20%), usually transient, mild to moderate\n- Alopecia is the most common type of hair loss, but usually less severe than in anti-epidermal growth factor-2 (EGFR) agents such as erlotinib.

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Does breast cancer run in families?

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Although familial breast cancer may have an important genetic basis, the proportion of families with a documented mutation is low, suggesting that further genetic investigations to discover new tumor-suppressor genes are urgently needed.

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How does pertuzumab work?

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Pertuzumab may induce a clinical benefit in HER2-positive breast cancer when taken with trastuzumab. Pertuzumab and trastuzumab could combination potentially serve as a safe and effective therapy in the patients previously treated with taxane chemotherapy. Patients with residual disease after a taxane based therapy (e.g. anthracycline or combinations) might be eligible for PERT in combination with trastuzumab (TRAC-P, NCT01385089).

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How quickly does breast cancer spread?

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We found that more than half of breast cancer patients develop axillary disease and half develop this disease within 10 years of diagnosis. The time interval between tumor detection and axillary pathology (median interval 11 months) has been shortened in recent years. Because this may be indicative of decreasing rates of sentinel node biopsy, the time to axillary metastatic disease may be underestimated. Prospective validation of current staging system is important because it may enhance prognostication and treatment approaches.

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What is the average age someone gets breast cancer?

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Women who are older than 50 have a higher mortality than women who have their first diagnosis of breast cancer before age 50. The average age women develop breast cancer in the United States is 47 years. The highest rate of breast cancer occurs in African American women (49.9 years; 95% CI, 47.1-51.9 years) and white women (49.4 years; 95% CI, 46.9-52.8 years) diagnosed before age 50; by age 70, almost three quarters (75.8%) survived to age 90 of that year. Most women (88%) survived for at least five years with their disease.

Unverified Answer

What is the primary cause of breast cancer?

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These data provide evidence to support genetic and environmental factors for breast cancer causation and also to propose the effects of hormones on disease risk. While the exact mechanism of breast cancer growth and progression are not fully understood, research in this field has advanced over the last two decades, and there is now convincing evidence that many breast cancers are caused by genetic mutations or by environmental exposure to various toxins and hormones. The current debate in the medical literature is concerned with the risk factors for the development of breast cancer and its prevention and treatment. In the United States, approximately 1 in every 8 women will develop the disease during their lifetime, and women are twice as likely to develop breast cancer on the left as on the right.

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