BREAST CANCER

The FDA has issued a complete response letter to Athenex, Inc, regarding the New Drug Application for oral paclitaxel in combination with encequidar for the treatment of metastatic breast cancer. The FDA stated that the application review process has been completed, but the NDA is not ready for approval due to safety and efficacy concerns.

Can treatment with inhibitors of cyclindependent kinases 4 and 6 be optimized for patients with breast cancer? This remains an open question 6 years after the first approval of a CDK4/6 inhibitor, palbociclib.

Patients with BRCA-mutated high-risk HER2-negative early breast cancer demonstrated a superior invasive disease-free survival when compared with placebo in the phase 3 OlympiA trial.

In a 10 to 0 vote, the FDA’s Oncology Drug Advisory Committee did not support the approval of pembrolizumab (Keytruda) in combination with chemotherapy as neoadjuvant therapy for high-risk, early-stage triple-negative breast cancer.

Final analysis of data on HER2-positive disease presented at the 2020 San Antonio Breast Cancer Symposium from experts in the field of breast oncology.

Experts in breast oncology discuss the evolving role of trastuzumab deruxtecan for metastatic HER2-positive breast cancer.

Hatem Soliman, MD, reviews statistically significant data from the PERTAIN study, presented at the 2020 San Antonio Breast Cancer Symposium.

Experts in breast oncology discuss their real-world experience with trastuzumab emtansine (T-DM1) for patients with advanced HER2-positive breast cancer.

Analysis from the ALTTO (BIG 2-06) trial and the relationship between a short or long disease-free interval and overall survival.

Updated findings on the use of neratinib for HER2+ breast cancer from the 2020 SABCS Virtual Symposium.

Updated findings on the use of neratinib for HER2+ breast cancer from the 2020 SABCS Virtual Symposium.

A discussion on the importance of prognostic tools for early stage breast cancer.

Hatem Soliman, MD, discusses data presented at the 2020 SABCS for patients with HER2-enriched subtypes that showed benefit from CDK4/6 inhibition.

Andrew Seidman, MD, provides insight on clinical sequencing for patients with advanced HER2-positive breast cancer.

Experts in breast oncology discuss the evolving landscape in early stage and metastatic HER2-positive breast cancer.

Halle Moore, MD, discusses the results of the IBIS-II DCIS trial of anastrozole versus tamoxifen after 12 years of follow-up for postmenopausal patients with locally excised ductal carcinoma in situ.

The virtual 38th Annual Miami Breast Cancer Conference®, hosted by Physicians’ Education Resource®, LLC will feature presentations from industry thought leaders on innovations in the arena of breast cancer treatment, including topics about systemic therapy and beyond.

In an interview with Targeted Oncology, Senthil Damodaran, MD, PhD, discussed the need for an ESR1-targeted agent for the postmenopausal women with ESR1-positive, locally advanced or metastatic ER-positive/HER2-negative breast cancer.

A review of key relevant data on HER2-positive breast cancer from the 2020 SABCS Virtual Symposium.

Patients with hormone receptor-positive and HER2-negative, aromatase inhibitor resistant metastatic breast cancer experienced improvement in progression-free survival on treatment with chemotherapy over palbociclib in combination with and endocrine therapy.

Erika P. Hamilton, MD, discusses the rationale for exploring OP-1250 monotherapy in an open-label first-in-human multi center phase 1/2 study in adult patients with advanced and/or metastatic hormone receptor-positive, HER2-negative breast cancer.

Earlier in the year, Javier Cortes, MD, PhD, presented progression-free survival results from the phase 3 KEYNOTE-355 clinical trial, which showed the importance of the addition of taxanes to a platinum-based regimen in the triple-negative breast cancer space.

Despite the success of CDK4/6 inhibitors in patients with advanced hormone receptor–positive, HER2-negative breast cancer, acquired resistance develops in many. For these patients, research indicates that treatment sequencing may soon include agents that act on implicated pathways of resistance.

Experts in oncology and hematology review some of the most impactful FDA approvals from 2020 in lung, breast, blood, gastrointestinal, and genitourinary cancers.

Following the 2020 San Antonio Breast Cancer Symposium, Erika P. Hamilton, MD, and William J. Gradishar, MD, shared their key takeaways and insights from the most impactful data presented during this year’s meeting.

Treatment with tesetaxel plus a reduced dose of capecitabine improved progression-free survival in patients with HER2–, HR+ metastatic breast cancer compared with the FDA-approved dose of capecitabine alone.

In the phase 3 PENELOPE-B clinical trial, adding 1 year of palbociclib to endocrine therapy did not demonstrate improvement in invasive disease-free survival in patients with hormone receptor–positive, HER2-negative breast cancer who are at high risk of relapse following neoadjuvant chemotherapy, according to results presented at the 2020 San Antonio Breast Cancer Symposium.

For patients with node-negative early breast cancer, RSClin, an intergration of the 21-gene expression assay and clinical pathologic features, provided more prognostic information compared with the 21-gene recurrence score or clinical pathologic features alone, as well as a more precise prediction of absolute chemotherapy benefit.

Using 5- HT3 inhibitors and early intervention with loperamide was shown to manage gastrointestinal adverse events oral paclitaxel and encequidar in patients with metastatic breast cancer, according to a study presented during the San Antonio Breast Cancer Symposium.

Sacituzumab govitecan led to improvements in response rates and progression-free survival (PFS) compared with chemotherapy for patients with metastatic triple-negative breast cancer who had stable brain metastases in a subgroup analysis from the phase 3 ASCENT trial.