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.

Afinitor, T-DM1 and Xeloda for Metastatic Breast Cancer

Today we'll share the latest news and research on Afinitor, T-DM1 and Xeloda for metastatic breast cancer.

Afinitor plus Aromasin (phase III)

The big story this week was a phase III trial of Afinitor (everolimus) plus Aromasin (exemestane) for post-menopausal women with advanced breast cancer presented at the 2011 European Multidisciplinary Cancer Congress (EMCC). Links to the EurekAlert!, Reuters and Bloomberg articles may be found on the Afinitor page of our website.

The trial, known as BOLERO 2, involved 724 hormone-receptor positive women whose cancer had become resistant to the aromatase inhibitors Femara (letrozole) or Arimidex (anastrazole). 485 received Afinitor plus Aromasin. 239 received Aromasin alone. Progression-free survival was almost 11 months in the Afinitor group, compared to about 4 months in the Aromasin alone group.

Afinitor is also being studied in combination with other drugs for advanced breast cancer. Novartis plans to file worldwide regulatory submissions for the Afinitor/Aromasin combination by the end of 2011.

TDM-1 (phase II)

Another EMCC presentation made headlines this week. The phase II study, TDM4450g, of trastuzumab emtansine (T-DM1) as first-line therapy in women with advanced HER2 positive breast cancer was covered by Medical News Today, Bloomberg and The Telegraph (UK).

The 137 patients were treated with either T-DM1 alone or Herceptin (trastuzumab) plus Taxotere (docetaxel). The median progression-free survival was 14.2 months with T-DM1 compared to 9.2 months with Herceptin plus Taxotere. In addition, the T-DM1 group suffered fewer side effects with less hair loss and hospitalization.

Larger, phase III trials are needed before regulatory approval. Last week, The Seattle Times shared an interesting story about Jeanne Sather, a breast cancer blogger whose efforts led to a geographic expansion of a T-DM1 trial. The story may be found on our T-DM1 page.

Navelbine/Gemzar vs. Xeloda alone (phase III)

Not all research on metastatic breast cancer involves brand new drugs. Some studies experiment with combinations of existing drugs.

A September 21 phase III study from Greece in the Annals of Oncology compared Navelbine (vinorelbine) plus Gemzar (gemcitabine) to oral Xeloda (capecitabine) alone for women with metastatic breast cancer previously treated with anthracyclines and taxanes.

Progression-free survival, overall survival and overall response were similar for both groups. The authors concluded, "Given the favorable toxicity and convenience of oral administration, single-agent capecitabine is recommended for compliant patients."

At LATESTBreastCancer.com, we'll continue to follow research on treatments for metastatic breast cancer. New developments will be added to our website and database and highlighted here. Please stay tuned.

The Breast Cancer News Update: July 11

Afinitor, also known as everolimus or RAD001, has been making breast cancer news lately. Today, we'll look at the latest news as well as the biology and the history of development of Afinitor for the treatment of breast cancer. All news and research may be found on the Afinitor (everolimus, RAD001) page of the LATESTBreastCancer.com website.

Afinitor: A little biology

Basically, Afinitor targets the mammalian target of rapamycin (mTOR), a protein kinase. According to a nice summary on Inhibiting the PI3K/Akt/mTOR Signaling Pathway from the National Cancer Institute, "mTOR is a critical regulator of several normal cell processes." Essentially, mTOR receives growth signals and regulates cell division, metabolism and blood vessel growth. In cancer cells, the signalling pathway that includes mTOR can become "highly active," resulting in a poor prognosis and increased likelihood of resistance to many types of therapy. Afinitor treats breast cancer by inhibiting mTOR.

The latest Afinitor news: Two studies for metastatic breast cancer

Last week, there were two announcements of positive study results of Afinitor for metastatic breast cancer.

Afinitor plus Aromasin for hormone therapy resistant breast cancer

On July 5, Reuters and RTT News covered results from a phase III study of Afinitor plus Aromasin (exemestane) to treat advanced cancer that had progressed on hormone therapy. The study was halted when its primary endpoint of progression free survival was met ahead of schedule. For women with resistance to hormonal therapy, the addition of Afinitor "has the potential to extend the time until chemotherapy is needed."

Aromasin plus Herceptin for Herceptin resistant breast cancer

On July 8, MD Anderson announced, via EurekAlert!, positive results of a phase I/II study involving the addition of Afinitor to Herceptin (trastuzumab) for HER2 positive metastatic breast cancer that had been resistant to previous Herceptin-based therapy. Despite the fact that most of the women in the study had received "multiple chemotherapy regimens," this "chemotherapy-free option" offered "additional clinical benefit and less toxicity for many" of the patients. Thirty-four percent of the women in the study benefited from the combination.

Afinitor Research History

One of the really unique features of the LATESTBreastCancer.com website is that it's very easy to see the entire history of the development of a drug. Afinitor is a good example. The development history can be seen under both the News Articles and Medical Journal Abstracts tabs.

Early research of Afinitor plus Aromasin or Herceptin

To learn more about the history of Afinitor plus Aromasin, we may look under the News tab to see a December 2010 Medical News Today story about the phase II study.

To see the early, pre-clinical research on Afinitor plus Herceptin, a December 2009 Clinical Cancer Research study, found the combination to be effective for the treatment of HER2 positive breast cancer in mice.

Afinitor plus Taxol and Herceptin

Both of the combinations above are chemotherapy-free options. Afinitor is also being studied in combination with Taxol (paclitaxel), a chemotherapy. Under the News tab, we see links to December 2008 and October 2009 Medical News Today coverage of early studies of the combination of Afinitor, Taxol (paclitaxel), and Herceptin. The October 2010 Journal of Clinical Oncology abstract of the phase I study can be found under the Medical Journal Abstracts tab.

Neoadjuvant (before surgery) therapy

Looking under the Medical Journal Abstracts tab, it is clear that Afinitor is not just being studied for advanced breast cancer. An April 2009 Journal of Clinical Oncology phase II study discovered that the addition of Afinitor "significantly increased" the efficacy of Femara (letrozole) in neoadjuvant therapy in postmenopausal women with operable breast cancer.

Similarly, an October 2010 Breast Cancer Research and Treatment study gave a small number of postmenopausal women with early breast cancer Afinitor alone once a day for 14 days before surgery. The treatment "significantly decreased proliferation," particularly for HER2 postitive cancer and tumors with high Ki67 and p-AKT.

Reviews of the history and future of Afinitor

Not all medical journal abstracts are studies. Often, scientists review all of the research on a treatment or type of treatment. Reviews often explain the biology, history and future potential for a new drug. Several such reviews exist for Afinitor. Under the Medical Journal Abstracts tab, we see reviews published in The Oncologist, Clinical Breast Cancer, the American Journal of Health-System Pharmacy, Breast Cancer Research, the Annals of Oncology, Current Opinion in Obstetrics and Gynecology and Seminars in Oncology.

At LATESTBreastCancer.com, we'll continue to follow developments in Afinitor for breast cancer. All future news and research will be added to the Afinitor page of our website. Please stay tuned.

The Breast Cancer News Update: July 6

Today in breast cancer news, we'll look at a successful study of Afinitor (everolimus) for advanced cancer. We'll also look at recent developments in breast cancer complementary therapies, including vitamin D, acupuncture and tumeric (curcumin).

Positive phase III study results for Afinitor (everolimus)

In a phase III randomized, double-blind, placebo-controlled study known as BOLERO-2, Afinitor (everolimus) plus Aromasin (exemestane) significantly extended progression-free survival for post-menopausal women with estrogen-receptor positive locally advanced or metastatic breast cancer when compared to placebo plus Aromasin. The study was halted when its goals were reached ahead of schedule. According to a statement from Novartis published in Reuters, the results suggest that the Afinitor/Aromasin combination "has the potential to extend the time until chemotherapy is needed for these patients." The results will be presented at a future medical conference. Regulatory submissions are planned by the end of 2011. Marketing approval is possible in early 2012. For more details, please see the link to the RTT News story on the Afinitor page of our site.

Vitamin D for aromatase inhibitor induced bone loss

Looking at the vitamin D page of our website, most studies this year involve breast cancer risk or prognosis. The June 21 Breast Cancer Research and Treatment study is different. As explained in a July 5 Internal Medicine News story, which can be found under the vitamin D page News tab, aromatase inhibitor induced bone loss was "significantly slowed with increasing supplements of vitamin D." "The magnitude of bone-loss prevention correlated with incremental increases" in serum vitamin D concentrations. According to the Internal Medicine News story,

The findings suggest that vitamin D supplementation at doses higher than standard of 400 to 800 IU/day might be useful to minimize bone loss in women starting out on aromatase inhibitors and who are not eligible for bisphosphonate therapy according to current guidelines.

Acupuncture for breast cancer fatigue

Looking at the acupuncture page of our website, acupuncture has been studied for breast cancer related joint pain, hot flashes and lymphedema. According to the latest study, published on June 25 in BMC Complementary and Alternative Medicine, acupuncture may also be useful to treat breast cancer fatigue. Although it was a small study due to recruitment problems, education on exercise and nutrition plus acupuncture seemed to reduce fatigue. Researchers concluded that the "very promising effect" warrants larger studies to confirm the findings.

Another tumeric (curcumin) study on cancer cells

Breast cancer patients are often interested in tumeric (curcumin) as a complementary therapy. Unfortunately, as our curcumin page shows, there haven't been any significant studies in humans. (There was one promising phase I French study in January 2010.) However, several studies on breast cancer cells have demonstrated anti-cancer activity. Curcumin has been tested as a chemosensitiser or radiotherapy sensitiser to make chemotherapy and radition more effective. The latest study from Germany, dated June 26, demonstrated curcumin's effect on cell growth and survival factors. We'll continue to follow developments in curcumin research and hope to see advanced trials in humans someday soon.

Please check back tomorrow for more breast cancer news and research updates. Until then, all breast cancer news and research for any test or treatment option, including complementary therapies, may be found on our LATESTBreastCancer.com website anytime. We update content daily.