Breast Cancer

Breast Cancer

Substantial investment in breast cancer research has led to advances in screening, treatment, and prevention over the last four decades. As a result, over 90 percent of breast cancers are diagnosed at an early age, surgery has become less invasive, and the development of more effective therapies have boosted cure rates to current highs. Crucial insights from genetics research have also led to new, preventive drugs and surgeries that have helped to reduce the risk of occurrence for women who are at high risk for the disease, including those predisposed as a result of genetic mutations.

Today, nine out of ten women are alive five years after diagnosis and mortality has fallen by more than a third since the 1980s. However, more research is still needed to develop better treatments for advanced stages and currently resistant forms of breast cancer, and to address profound racial disparities in breast cancer mortality. 

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2019

Targeted Therapy Ribociclib Added to Endocrine Therapy Improves Survival in Young Women with Certain Types of Breast Cancer

Targeted Therapy Ribociclib Added to Endocrine Therapy Improves Survival in Young Women with Certain Types of Breast Cancer

The combination of the CDK4/6 inhibitor ribociclib with endocrine therapy provided an overall survival advantage for pre- and perimenopausal women with advanced HR+, HER2- breast cancer, compared to standard endocrine therapy plus placebo. Results from the MONALEESA-7 trial showed 42-month survival with ribociclib of 70.2%, compared with 46% for women who received placebo plus standard endocrine treatment. The treatment combination is an important step forward for the treatment of younger women with this disease, who tend to have more aggressive disease with worse survival than those who are postmenopausal.

 

2018

Treatment targets BRCA mutations in breast cancer

Treatment targets BRCA mutations in breast cancer

Findings from a large clinical trial of women with advanced, germline BRCA mutation-related breast cancer show that the PARP inhibitor olaparib (Lynparza) lowers the risk of cancer progression, with fewer side effects, compared to standard chemotherapy. Based on these data, olaparib is approved for this use by FDA, marking the first time any drug has been approved to treat certain patients with a BRCA gene mutation who have metastatic breast cancer. Up to 3% of all breast cancers are related to inherited changes in the BRCA1 and BRCA2 genes, which affect a cell’s ability to repair damaged DNA. PARP inhibitors further block DNA repair in cancer cells, which helps slow or stall tumor growth.

21-Gene Expression Assay Guides Choice of Adjuvant Therapy for Certain Patients with Breast Cancer

21-Gene Expression Assay Guides Choice of Adjuvant Therapy for Certain Patients with Breast Cancer

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A 21-gene-based test (Oncotype DX) predicts risk of recurrence and guides adjuvant therapy for women with low and high risk of recurrence of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2) negative, lymph node-negative breast cancer. Women at low risk for recurrence can receive endocrine therapy alone, while those at high risk receive chemoendocrine therapy. However, it is unclear how to treat women with intermediate risk. The TAILORx trial shows that for women with test results indicating an intermediate risk of recurrence, chemotherapy is no longer needed as endocrine therapy alone results in comparable survival.

Osimertinib Becomes Standard First-line Therapy for Untreated EGFR-Mutated Advanced NSCLC

Osimertinib Becomes Standard First-line Therapy for Untreated EGFR-Mutated Advanced NSCLC

  Osimertinib (Tagrisso) is an oral, third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that selectively inhibits EGFR-TKI-sensitizing and EGFR T790M resistance mutations. In the FLAURA trial, progression free survival is prolonged by nearly 80% with osimertinib versus two standard EGFR-TKIs in patients with previously untreated, EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). In a second trial (AURA3), osimertinib is associated with improvements in global health status/quality of life compared with chemotherapy. Osimertinib is approved in 2018 for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. It becomes the new standard front-line therapy for patients with confirmed T790M-positive NSCLC that has relapsed after first-line therapy with other EGFR-TKIs.

First Immunotherapy Approved for Metastatic Triple-Negative Breast Cancer

First Immunotherapy Approved for Metastatic Triple-Negative Breast Cancer

Atezolizumab in combination with chemotherapy is not only the first immunotherapy approved for breast cancer, but also an important advance for patients with advanced triple-negative breast cancer, which has an extremely poor prognosis. The FDA approval of the immunotherapy combination — PD-L1 targeted therapy atezolizumab with nanoparticle albumin-bound [nab] paclitaxel — was largely based on the results of the IMpassion130 trial. Progression-free survival was improved among patients with tumors that expressed PD-L1 who received atezolizumab in combination with nab paclitaxel.

2017

Targeted drug combination proves more potent for HER2-positive breast cancer

Targeted drug combination proves more potent for HER2-positive breast cancer

A major study of women with early-stage HER2-positive breast cancer shows that adjuvant treatment with two drugs that target the HER2 protein – pertuzumab (Perjeta) and trastuzumab (Herceptin) – together with standard chemotherapy substantially reduces the risk of  local or regional invasive breast cancer recurrence, distant recurrence, invasive breast cancer in the opposite breast, or death from any cause. in women with breast cancer that overproduces the HER2 protein. Importantly, the dual-targeted treatment does not increase in the rate of heart problems, a major concern with HER2-targeted therapy. The FDA approves pertuzumab for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.

Cyclin-Dependent Kinase 4/6 Inhibitor as Initial Therapy Extends Survival for Advanced HR+ HER2- Breast Cancer

Cyclin-Dependent Kinase 4/6 Inhibitor as Initial Therapy Extends Survival for Advanced HR+ HER2- Breast Cancer

Abemaciclib (Verzenio) is a type of targeted therapy that inhibits cyclin-dependent kinases (CDK) 4 and 6, which play roles in breast carcinogenesis and endocrine therapy resistance. In two studies, treatment with abemaciclib — either alone versus endocrine therapy or in addition to nonsteroidal endocrine therapy — results in improved progression-free survival for patients with metastatic hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. These findings lead to the approval of abemaciclib as the first CDK 4/6 inhibitor for use as monotherapy in patients previously treated with endocrine therapy and chemotherapy in the metastatic setting.

2015

A new class of breast cancer treatment introduced

A new class of breast cancer treatment introduced

2015-2016

Palbociclib (Ibrance) becomes the first in a new class of medicines called cyclin-dependent kinase (CDK) inhibitors, which block key proteins that control cell division. In clinical trials, addition of palbociclib to standard hormone therapy extended the time until the cancer worsened by a median of 11 months when given as initial therapy and by about 5 months for women with previously treated cancer. In 2015, the FDA grants accelerated approval to palbociclib in combination with letrozole (Femara) as initial hormone-based therapy in post-menopausal women with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. In 2016, the FDA grants accelerated approval to palbociclib with fulvestrant (Faslodex) to treat advanced breast cancer that worsens following initial hormone therapy.  

2012

"Armed-antibody" drug improves survival for women with resistant HER2 positive cancers

"Armed-antibody" drug improves survival for women with resistant HER2 positive cancers

A clinical trial shows that a next-generation targeted drug called trastuzumab emtansine (T-DM1; Kadcyla) extends survival in women with HER2-positive breast cancers that progress despite other standard therapies. This drug combines two anticancer drugs – the HER2-targeted drug trastuzumab and the chemotherapy drug emtansine. The drug is designed to bind to the HER2 protein on cancer cells and directly deliver these drugs to the tumor, minimizing adverse effects to healthy tissue in the body.

The FDA approves T-DM1 for breast cancer in 2013

Two targeted drugs together are more potent than one for HER2-positive breast cancer

Two targeted drugs together are more potent than one for HER2-positive breast cancer

A study shows that initial treatment with two drugs that target the HER2 protein – pertuzumab (Perjeta) and trastuzumab (Herceptin) – together with standard chemotherapy substantially slows cancer growth in women advanced with breast cancer that over-produces the HER2 protein.

The results add new momentum to research exploring the effectiveness of combining two or more drugs that target the same molecular pathways.

2011

Aromatase inhibitors cut breast cancer risk in postmenopausal women

Aromatase inhibitors cut breast cancer risk in postmenopausal women

2011-2014

A large Phase III trial shows for the first time that exemestane (Aromasin) – part of a group of drugs called aromatase inhibitors – greatly lowers the chance of developing invasive breast cancer in postmenopausal women who are at high risk for breast cancer. This includes women with BRCA gene mutations, as well as other risk factors. In 2014, another aromatase inhibitor, anastrozole (Arimidex), was shown to lower the risk of breast cancer by nearly 50% over five years.

Two other drugs, tamoxifen (Nolvadex) and raloxifene (Evista), are also FDA-approved for breast cancer prevention in women at high risk for the disease Aromatase inhibitors work differently, however, and tend to carry milder side effects.

2010

New chemotherapy drug improves survival for advanced breast cancer
Removing fewer lymph nodes for some breast cancer patients does not impair survival

Removing fewer lymph nodes for some breast cancer patients does not impair survival

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Two large clinical trials confirm that less extensive lymph node surgery in women with early-stage disease does not reduce their likelihood of survival. Specifically, researchers find that removing additional underarm lymph nodes to look for breast cancer in women with limited or no disease spread in the "sentinel" node – where cancer is most likely to spread – does not make a significant difference in survival, compared to removing fewer nodes. Removing fewer nodes decreases the risk of side effects, such as pain and swelling in the affected arm.

Targeted drug denosumumab helps prevent common bone-related complications in advanced breast cancer

Targeted drug denosumumab helps prevent common bone-related complications in advanced breast cancer

About 80 percent of women with metastatic breast cancer experience cancer spread to the bone, a complication that causes pain, bone weakening and other side effects that affect quality of life. In 2010, a large study shows that the targeted drug called denosumumab (Xgeva) can prevent or significantly delay bone metastases. Other drugs, such as zoledronic acid (Zometa), have previously been used to prevent and treat these bone-related complications, but this study suggests denosumumab may be more effective.

2009

PARP inhibitors show promise for difficult-to-treat breast cancers

PARP inhibitors show promise for difficult-to-treat breast cancers

Researchers share the first encouraging findings on a new class of targeted drugs – PARP inhibitors – for difficult-to-treat "triple-negative" breast cancers and those that involve BRCA1 and BRCA2 gene mutations. PARP inhibitors are designed to disable key enzymes that cancer cells use to repair DNA damage, including damage inflicted by chemotherapy, and to promote cancer cell death. They may also make cancer cells more sensitive to other chemotherapy agents. Triple-negative breast cancers lack receptors for estrogen, progesterone and HER2, and therefore do not respond to targeted drugs that block these proteins.

Further long-term, randomized clinical trials are needed to determine whether PARP inhibitors truly benefit patients with breast cancer, and if so, which specific types of breast tumors are most likely to respond to the drugs.

Standard chemotherapy is an option for older women

Standard chemotherapy is an option for older women

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Researchers find that chemotherapy with capecitabine (Xeloda) alone is less effective and is associated with more serious side effects among older women with early-stage breast cancer than the three-drug chemotherapy regimen that younger women typically receive. The finding resolves a long-running debate about whether a single oral drug would be more tolerable or more effective than a combination of drugs for older patients, showing that otherwise healthy elderly patients can tolerate and benefit from the standard treatment regimen.

Preventive surgery confirmed to reduce breast and ovarian cancer risk in women with BRCA gene mutations

Preventive surgery confirmed to reduce breast and ovarian cancer risk in women with BRCA gene mutations

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A major review of previously published studies confirms that surgical removal of the ovaries and fallopian tubes in healthy premenopausal women with BRCA gene mutations reduces the risk of breast cancer by 51 percent and the risk of ovarian and fallopian tube cancers by 79 percent. Among postmenopausal women with BRCA gene mutations, this surgery is found to significantly reduce the incidence of ovarian cancer but not breast cancer.

Without the surgery, women with inherited mutations in the two BRCA genes have up to an 84 percent lifetime risk of breast cancer and up to a 46 percent risk of ovarian and fallopian tube cancers. With these data, women with these mutations have a proven option for reducing their cancer risk, although it comes with many side effects (including early-onset menopause) and prevents women of child-bearing age from having children.

2008

Bevacizumab (Avastin) approved for advanced breast cancer

Bevacizumab (Avastin) approved for advanced breast cancer

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In 2008, the FDA grants accelerated approval for bevacizumab (Avastin) in combination with paclitaxel (Taxol) for women with newly diagnosed advanced breast cancers. Bevacizumab is an "anti-angiogenic" drug, meaning that it works by interfering with the growth of the blood vessels that tumors need to grow and spread. The approval is based on studies showing this regimen delays cancer growth. However, later, longer-term studies show that bevacizumab does not extend survival. Debate continues about the use of this drug for breast cancer, although it has an established role in the treatment of other common cancers, such as lung and colorectal cancers.

2007

Declining breast cancer incidence linked to lower use of hormone replacement therapy

Declining breast cancer incidence linked to lower use of hormone replacement therapy

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Studies link declines in breast cancer incidence in women aged 50 and older to decreased use of hormone replacement therapy involving estrogen and progestin. One study reports that the rate of new breast cancer cases declined as much as 13 percent between 2001 and 2003, though researchers suggest other factors could have also played a role, such as increased use of mammography. Until 2002, when researchers first identified this significantly increased breast cancer risk, hormone replacement therapy was commonly prescribed to relieve the symptoms of menopause, such as hot flashes and vaginal dryness.

MRI screening recommended for women at high risk of breast cancer

MRI screening recommended for women at high risk of breast cancer

Based on new studies demonstrating its effectiveness, the American Cancer Society releases guidelines recommending routine MRI screening for women at increased risk of developing breast cancer, in combination with standard mammography. MRI is more sensitive than mammography for finding breast lesions, particularly in women with dense breast tissue that is difficult to assess using traditional mammography. Routine MRI is not recommended for the general population of women (those not at increased risk), due to its high cost and the likelihood that it will detect abnormalities that are not cancerous.

Shorter course of radiation therapy is as effective as less frequent radiation therapy for early-stage breast cancer

Shorter course of radiation therapy is as effective as less frequent radiation therapy for early-stage breast cancer

Findings from the START Trial suggest that "hypofractionated" radiation therapy, which involves fewer but larger doses of radiation delivered over a shorter period of time, is as effective as conventional radiation for reducing the risk of cancer recurrence among women with early-stage breast cancer, and does not cause greater damage to healthy breast tissue. Since traditional radiation therapy for breast cancer can take five to six weeks to complete, this shorter course (as little as three weeks) is a more convenient option for some patients and makes it easier to complete all cycles of treatment.

Lapatinib approved for patients whose HER2-positive breast cancer no longer responds to trastuzumab

Lapatinib approved for patients whose HER2-positive breast cancer no longer responds to trastuzumab

The targeted therapy lapatinib (Tykerb) is approved by the FDA for use in combination with the drug capecitabine for patients with advanced breast cancer whose tumors overproduce the HER2 protein. Lapatinib is used to slow disease progression in cancers that no longer respond to trastuzumab (Herceptin). In 2010, the drug is also approved as an initial therapy in combination with the aromatase inhibitor letrozole (Femara) for patients with HER2-positive cancer.

First in new class of drugs approved for advanced breast cancer that resists other treatments

First in new class of drugs approved for advanced breast cancer that resists other treatments

The FDA approval of ixabepilone (Ixempra) offers a new treatment option to stop or slow the growth of tumors in women whose advanced breast cancer no longer responds to any other chemotherapy. The drug is used as a single therapy or in combination with the chemotherapy drug capecitabine. Ixabepilone is part of a new class of chemotherapy drugs called epothilones, which fight the disease by preventing cancer cells from dividing.

2006

Many breast cancer survivors experience fatigue

Many breast cancer survivors experience fatigue

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A large study shows more than one-third of long-term breast cancer survivors report elevated fatigue 5 to 10 years after their cancer diagnosis. Women in the study had completed all cancer therapies other than tamoxifen (Novaldex). The findings suggest that persistent fatigue may be common among breast cancer survivors, and heightens awareness of this symptom among healthcare providers and caregivers.

Tamoxifen and raloxifene equally effective for preventing invasive breast cancer

Tamoxifen and raloxifene equally effective for preventing invasive breast cancer

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Findings from one of the largest-ever breast cancer prevention studies show that tamoxifen (Novaldex) and a newer drug, raloxifene (Evista), are equally effective in reducing the risk of invasive breast cancer in women at high risk for the disease. (Both drugs lowered the risk by about 50 percent.) The study found that raloxifene was not as effective, however, at reducing non-invasive breast cancer, such as ductal carcinoma in situ. Tamoxifen had greater side effects, including a higher risk of blood clots and uterine cancers.

Screening, treatment key to declining U.S. breast cancer mortality

Screening, treatment key to declining U.S. breast cancer mortality

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The National Cancer Institute announces that the death rate from breast cancer dropped by nearly 24 percent between 1994 and 2000, after being nearly flat from 1975 to 1990. The agency concludes that mammograms accounted for 28 to 65 percent of this decline, and the remainder was due to advances in the use of chemotherapy after surgery – a now-standard approach known as adjuvant chemotherapy.

2005

Digital mammography more accurate than standard mammography in younger women

Digital mammography more accurate than standard mammography in younger women

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A study of more than 42,000 women reports that digital mammography is more sensitive than traditional film mammography for women under age 50, who are more likely to have dense breast tissue, which is more difficult to assess. Digital mammography enables the radiologist to alter features such as brightness and contrast, improving the detection of abnormalities in breast tissue.

Low-fat diet and regular exercise may reduce risk of breast cancer recurrence

Low-fat diet and regular exercise may reduce risk of breast cancer recurrence

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Two large clinical trials suggest that lifestyle changes, including a low-fat diet and exercise, decrease the risk of breast cancer recurrence and death in women with early-stage breast cancer. The findings are among the first to demonstrate that healthy lifestyle changes can have a substantial impact on breast cancer outcomes.

2004

Docetaxel helps reduce breast cancer recurrence

Docetaxel helps reduce breast cancer recurrence

Docetaxel (Taxotere), a chemical cousin of paclitaxel (Taxol) that blocks cell division, is shown to decrease the risk of cancer recurrence by more than 25 percent and increase survival among women with operable breast cancer that has spread to the lymph nodes, compared to the previous standard therapy, fluorouracil. The FDA approval of docetaxel later the same year expands the arsenal of chemotherapy drugs for women with breast cancer.

Adding new drug, gemcitabine, extends survival for some women with advanced breast cancer
New class of drugs, aromatase inhibitors, introduced

New class of drugs, aromatase inhibitors, introduced

The FDA approves the drug letrozole (Femara), the first in a new class of drugs called aromatase inhibitors that block an enzyme the body needs to make estrogen (estrogen fuels the growth of some breast cancers). The drug is first approved for long-term use in post-menopausal women who have completed five years of tamoxifen (Novaldex) treatment, based on studies showing letrozole reduces the risk of breast cancer recurrence and spread even more than tamoxifen alone. In 2005, letrozole is also approved as an initial therapy following surgery for post-menopausal women.

In the same time period, additional trials show that aromatase inhibitors, including letrozole and similar drugs like anastrazole (Arimidex), also improve survival and alleviate the symptoms of cancer for post-menopausal women with advanced breast cancer.

2003

Higher density, shorter term chemotherapy improves breast cancer survival

2002

Novel genetic tests help guide breast cancer therapy

Novel genetic tests help guide breast cancer therapy

Several gene tests are shown to be powerful predictors of outcomes for patients with breast cancer, including the likelihood of cancer recurrence and the potential to benefit from more aggressive treatment. One such test, OncoType DX, helps doctors identify select patients (whose tumors are fueled by estrogen and have not spread to the nearby lymph nodes) who need additional, potentially lifesaving chemotherapy to prevent cancer recurrence, while sparing those who do not need additional chemotherapy from the related side effects and costs.

2000

Breast cancer subtypes identified

Breast cancer subtypes identified

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After sequencing the genetics of the tumors of 42 patients, researchers gain deeper insight about how to distinguish various breast cancer subtypes. These findings add to growing knowledge about the use of "molecular profiling," which is increasingly used to categorize tumors into one of at least four breast cancer subtypes and personalize therapy based on the genetic make-up of a patient's tumor.

High-dose chemotherapy plus stem cell transplant does not improve breast cancer survival

High-dose chemotherapy plus stem cell transplant does not improve breast cancer survival

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In several large, randomized studies, researchers demonstrate conclusively that high-dose chemotherapy with supportive stem-cell or bone marrow transplantation does not improve survival among women with advanced breast cancer or earlier-stage cancer. These results immediately change practice. (Based on the results of earlier small-scale studies, the approach came into widespread use for both advanced and early-stage breast cancer patients – well before large, randomized clinical trials were conducted.) The approach involves administering extremely high doses of chemotherapy to fight the cancer, which had been used successfully in other cancers such as lymphoma and leukemia. However, because such high doses destroy bone marrow, they are fatal if not supported by bone marrow transplantation or stem cell support, which repopulate these vital cells. The negative trial results underscore the importance of confirming preliminary data from uncontrolled pilot trials in more definitive phase III studies.