Metastatic Breast Cancer News from the 2011 San Antonio Breast Cancer Symposium

Today we'll continue to cover headlines from the 2011 San Antonio Breast Cancer Symposium, with a focus on six studies relevant to women with metastatic breast cancer.

Links may be found on the treatment pages of our LATESTBreastCancer.com website.

Omnitarg for HER2 positive metastatic breast cancer

The phase III Omnitarg (pertuzumab) study, known as CLEOPATRA (CLinical Evaluation Of Pertuzumab and TRAstuzumab), was big news. Reuters, Medical News Today, The New York Times and Los Angeles Times all ran stories. The study was published in the New England Journal of Medicine on December 7. (Link to full text.)

In the study, 808 women with HER2 positive metastatic breast cancer were randomly assigned to receive Herceptin (trastuzumab) and Taxotere (docetaxel) either with or without Omnitarg.

For the Omnitarg group, median progression-free survival, meaning the amount of time the cancer remains stable, was 18.5 months compared to 12.4 months for the Herceptin/Taxotere only group.

Although it's too early to confirm overall survival data, preliminary results show 69 deaths among the 402 women treated with Omnitarg compared to 96 deaths among the 406 women who did not receive Omnitarg.

Genentech and its parent company, Roche, have applied for permission to market Omnitarg in the US and Europe as first-line treatment for HER2 positive metastatic breast cancer.

Avastin for HER2 positive metastatic breast cancer

After the recent FDA decision to pull approval of Avastin for metastatic patients, there has been interest in identifying subsets of patients who may benefit from Avastin.

The phase III study (AVEREL) of Avastin (bevacizumab) in HER2 positive metastatic patients was similar in design to the Omnitarg study. 208 women were treated with Herceptin and Taxotere alone. 216 also received Avastin. The New York Times, Los Angeles Times and US News and World Report/HealthDay covered the study.

For the Avastin group, progression-free survival was 16.5 months, compared to 13.7 months for the 208 in the Herceptin/Taxotere only group.

But some question whether small benefits in progression-free survival are important.

According to the New York Times, "there was absolutely no difference in how long the women lived." Genentech has decided not to apply for FDA approval for HER2 positive breast cancer. A company representative noted, "Our bottom line is we do not believe that the difference in P.F.S. is of a sufficient magnitude that it is likely to gain regulatory approval."

Future research will attempt to identify the subset of patients who benefit from Avastin. As Dr. Gabriel Hortobagyi from MD Anderson noted in Los Angeles Times,

"I have no doubt that Avastin is a very powerful drug for some patients. . . The problem with Avastin is we don’t have a biomarker to help us identify the sub-group."

Afinitor for hormone-receptor positive metastatic breast cancer

A study (BOLERO-2) of Afinitor (everolimus) involving 704 women with hormone-receptor positive breast cancer which progressed on prior hormone therapy was covered by The New York Times, Los Angeles Times and Medical News Today. The study was published in The New England Journal of Medicine on December 7. (Link to full text.)

For women who took Afinitor plus the aromatase inhibitor Aromasin (exemestane), median progression-free survival was 7.4 months, compared to 3.2 months for women who took Aromasin alone.

However, the New York Times (Dec. 7) noted that because all women had already failed to benefit from hormone therapy, "perhaps it is not surprising that the control arm did not do that well on exemestane alone."

But, the trial researchers said that doctors often prescribe Aromasin in practice when other hormone therapies fail.

Medical News Today quoted Dr. Hortobagyi, a study coauthor, to say, "These findings may establish a new standard of care for advanced breast cancer."

Faslodex for hormone-receptor positive metastatic breast cancer

A phase III trial (SWOG S0226) of Faslodex (fulvestrant) plus Arimidex (anastrozole) for women with hormone-receptor positive metastatic breast cancer was covered by the Medical News Today on December 9.

In the study, 707 postmenopausal women were assigned to receive Arimidex plus Faslodex or Arimidex alone. Compared to the Arimidex alone arm, the Faslodex arm experienced longer median overall survival (47.7 months vs. 41.3 months) and longer progression-free survival (15 months vs. 13.5 months).

Both Arimidex and Faslodex are already used to treat breast cancer, though not in comination. The lead study coordinator noted that "these patients have not had a new treatment that gave them an overall survival benefit in more than a decade."

Entinostat for hormone-receptor positive metastatic breast cancer

A small phase II study (ENCORE 301) of entinostat for locally recurrent or metatstatic breast cancer was covered in a PR Newswire press release and the New York Times (Dec. 7)

In the study, 130 patients were treated with Aromasin (exemestane) alone or Aromasin plus entinostat. The median overall survival for the entinostat group was 26.9 months, compared to 19.8 months in the Aromasin alone group. Progression-free survival was also better with entinostat (4.3 months vs. 2.3 months.)

A randomized phase III study is anticipated to begin enrollment in the first half of 2012.

Abraxane as first-line treatment for metastatic breast cancer

A phase II study comparing Abraxane (nab-paclitaxel) to Taxotere (docetaxel) as first-line therapy for metastatic breast cancer was covered by Medical News Today on December 12.

In the study, 300 women who received no prior chemotherapy for metastatic disease were divided into four groups. Three groups received different doses of Abraxane. The fourth group received Taxotere.

The best median overall survival was achieved by the group that received 150 mg of Abraxane twice weekly (33.8 months.) The other two Abraxane dose schedules achieved median overall survival of 22.2 months and 27.7 months. For the Taxotere group, median overall survival was 26.6 months.

Progression-free survival was also better for the Abraxane 150mg/twice weekly group at 14.6 months, compared to 7.5 months and 10.9 months for the other Abraxane doses and 7.8 months for the Taxotere group.


We'll continue to follow research developments for women with metastatic breast cancer. We add links to media stories and journal abstracts to our website, LATESTBreastCancer.com everyday. The latest news and research may be explored anytime by clicking the Treatments tab.

Media Headlines from the 2011 Breast Cancer Symposium

Breast Cancer Symposium 2011 is underway in San Francisco this week. Today we'll share the media coverage of some of the presentations.

Medical News Today: "Young Women With Early Breast Cancer Have Similar Survival With Breast Conservation, Mastectomy"

More young women under 40 with breast cancer are choosing mastectomy over breast conserving surgery (lumpectomy), in part because of concerns about recurrence. Two presentations suggest that there is no survival difference between women treated with a mastectomy and those treated with a lumpectomy plus radiation.

US News and World Report wrote about both studies. The first, presented a few days ahead of the Symposium, evaluated medical records of 628 women aged 21 to 40. Local recurrence and survival rates were similar for women treated with mastectomy and women treated with lumpectomy.

According to Medical News Today, the second study reviewed the records of nearly 15,000 women under 40 with breast cancer. Overall survival was similar between women treated with mastectomy and those treated with lumpectomy plus radiation. When women were matched with others with similar cancer characteristics, such as tumor size and lymph node involvement, there was no difference in overall survival.

HemOnc Today: "New tool may help predict breast-cancer-associated lymphedema"

On September 8, HemOnc Today shared a Brazilian study of a model to predict lymphedema before axillary lymph node dissection. The statistical model "demonstrated more than 70% accuracy for predicting the 5-year risk for developing lymphedema after lymph node removal during breast cancer surgery."

Dr. Jose Bevilacqua, a study author, noted that the model used "readily available clinical factors," such as age, BMI and number of chemotherapy cycles, for a "quick and easy estimation of individual risks of developing lymphedema after axillary lymph node surgery in women with breast cancer."

Drugs.com: "Syndax Pharmaceutical's Positive Phase 2 Data Supports Potential for Entinostat in Advanced Breast Cancer"

On September 6, Drugs.com printed a press release from Syndax about a positive phase 2 study of entinostat for advanced breast cancer.

For post-menopausal women with estrogen-receptor positive metastatic breast cancer, entinostat plus Aromasin (exemestane) improved progression-free survival and overall survival compared to placebo plus Aromasin.

A phase 3 trial is planned for early 2012.

US News and World Report: "Annual Breast Exams, Mammograms Still Key to Detecting Breast Cancer"

There's more fuel in the screening mammography debate. On September 6, US News and World Report/HealthDay covered a study from Michigan which reviewed breast cancer detection and treatment records from almost 6,000 women with breast cancer.

Overall, breast cancer detected by palpitation (feel) tended to be later-stage and more likely to be treated with a mastectomy and chemotherapy compared to breast cancer detected by mammography.

For women under 50, 48% of breast cancers were detected by mammography and 46% by palpitation. Dr. Andrew Seidman, an official of the American Society of Clinical Oncology (ASCO), said, "Undoubtedly, this area will continue to remain an area of controversy for some, but certainly women in this age group would be well-served to know about this data."


Not every study we add to the LATESTBreastCancer.com website and database makes media headlines. Next week, we'll highlight some new research which is under the media radar. Please stay tuned.

The Importance of Radiation for Triple-Negative Breast Cancer

Radiation therapy, which is standard treatment for many breast cancers, may be especially important for triple-negative breast cancer.

Triple-negative breast cancer, by definition estrogen-receptor, progesterone-receptor and HER2 negative, does not have as many treatment options as other breast cancers. Hormonal therapy and Herceptin (trastuzumab) for HER2 positive cancer are not effective.

Two recent studies highlighted the importance of radiation for triple-negative breast cancer.

Lumpectomy plus radiation better than mastectomy alone

A July 20 study in the Journal of Clinical Oncology found that women with small, node-negative, triple-negative breast cancer treated with mastectomy alone had a "significant increased risk" of local-regional recurrence compared to women treated with lumpectomy (breast conserving surgery) plus radiation. The authors noted that future studies are warranted to investigate the benefit of radiation after mastectomy in triple-negative breast cancer.

After mastectomy, chemotherapy plus radiation better than chemotherapy alone

Almost on cue, an August 16 study in Radiotherapy and Oncology evaluated the benefit of radiation after mastectomy in triple-negative breast cancer. (Link may be found on the postmastectomy radiotherapy (PMRT) page of our website.)

For women with early-stage triple-negative breast cancer treated with a mastectomy, chemotherapy plus radiation was "more effective" than chemotherapy alone. Recurrence rates and overall survival rates were significantly better in the group treated with radiation.

In both studies, women with triple-negative breast cancer treated with radiation fared better than those not treated with radiation.

Triple-negative breast cancer is a special situation. At our LATESTBreastCancer.com website, subscribers may create a profile based on their personal diagnosis to see the latest breast cancer news and research applicable to them. Our goal is to make internet research more efficient, and less overwhelming, for women with breast cancer.

The Breast Cancer News Update: June 28

Most of the press attention yesterday was given to a study out of MD Anderson showing that many physicians are not following medical guidelines related to delivery of radiation after mastectomy. In another story with big treatment implications a Yale study that found a very high rate of ER-positive women misclassified as ER-negative. Finally, the Avastin battle continues at a Genentech-requested FDA hearing this week.

Who needs radiation after mastectomy?
Researchers at MD Anderson found that many physicians are wrongly omitting radiation therapy after mastectomy to older breast cancer patients. Multiple guidelines call for radiation treatment after mastectomy in cases of high risk, advanced disease patients. Stories appear on both the Mastectomy and Radiation therapy pages.

ER (falsely) negative
Accurately determining hormone receptor status is absolutely critical for planning breast cancer treatment. Yet a Yale study found that between 10-20% of women who were told their tumors are ER negative (and thus not candidates for hormonal therapies like tamoxifen and aromatase inhibitors) were in fact ER positive and so should have received those drugs. Click on the first (most recent) news story listed on or ER (Estrogen Receptor) testing page.

Avastin battle rages on
The FDA's Center for Drug Evaluation and Research (CDER) is holding a hearing this week at the request of the drug's maker, Roche/Genentech, to reconsider its decision to rescind the drug's breast cancer indication. Several articles can be found under the News tab on our Avastin page.

The Breast Cancer News Daily Update: May 6

It's Friday. Today we'll cover the morning breast cancer news and highlight the noteworthy abstracts from medical research publications we added to our database this week.

First the news.

This morning, The Telegraph (UK) reported that tamoxifen only reduces risk of breast cancer in about half of the women who take it for breast cancer prevention.

The screening mammography discussion continued today with a Reuters story about the impact of the US Preventative Services Task force recommendation against mammograms for women in their 40s on minority women. According to the report, "minority women are more likely to develop breast cancer in their forties than white women."

In prognostic testing, Irish and American researchers compared the OncotypeDX test to the PAM50 test. According to the story in Medical News Today, the tests predicted similar risk for those with high and low risk. For those with intermediate risk, the PAM50 identified more patients who would not benefit from chemotherapy.

Also in prognostic testing, French researchers reported that baseline circulating tumor cell (CTC) counts are prognostic at baseline for metastatic patients, and that CTC changes during treatment, "may be an early indicator of chemotherapy efficiency."

This week, we added a few interesting abstracts from breast cancer research medical publications to our database.

Researchers in Chicago reviewed hospital and emergency room admission records to see which 5-HT(3) RA class drugs for chemotherapy-related nausea and vomiting were most effective. They concluded that breast cancer patients on cyclophosphamide-based chemotherapy had "a significantly lower risk" of hospital-related nausea and vomiting if they started and continued taking palonosetron (brand name Aloxi).

The Annals of Plastic Surgery published a study that found "nearly 1 in 5" healthy breasts removed during a contralateral prophylactic mastectomy contained a malignant or pre-malignant lesion. Risk factors for finding a malignancy in a healthy breast included "a lobular histology in the original specimen" and patient age over 54.

In the UK, a study in The British Journal of Cancer found clinical benefit in continuing trastuzumab (brand name Herceptin) beyond disease progression in patients with locally advanced or metastatic HER2 positive disease.

Please check back Sunday evening for a recap of the weekend breast cancer news. As always, at LATESTBreastCancer.com we welcome any and all feedback. We want to know what interests you most.