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Promising combo for tough breast cancer hits early roadblock

NCT ID NCT04216472

First seen Nov 01, 2025 · Last updated Jun 20, 2026 · Updated 36 times

Summary

This phase 2 trial tested a combination of nab-paclitaxel (a chemotherapy) and alpelisib (a targeted drug) in people with triple-negative breast cancer that has specific genetic changes (PIK3CA or PTEN) and did not respond to standard chemotherapy. The goal was to see if the combo could shrink tumors before surgery. However, the study was terminated early after enrolling only 6 participants, so we have very little data on how well it works or its safety.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

Nab-paclitaxel (a chemotherapy drug) and alpelisib (a targeted therapy)

What this could lead to

If successful, this combination could shrink tumors before surgery in a hard-to-treat breast cancer type.

What could go wrong

The trial was terminated early with only 6 participants, so results are very limited. It is a small, early-phase study, and the treatment may not work or may cause significant side effects.

Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ANATOMIC STAGE I BREAST CANCER AJCC V8 ANATOMIC STAGE I BREAST CANCER AJCC V8 ANATOMIC STAGE IA BREAST CANCER AJCC V8 ANATOMIC STAGE IA BREAST CANCER AJCC V8 ANATOMIC STAGE IB BREAST CANCER AJCC V8 ANATOMIC STAGE IB BREAST CANCER AJCC V8 ANATOMIC STAGE II BREAST CANCER AJCC V8 ANATOMIC STAGE II BREAST CANCER AJCC V8 ANATOMIC STAGE IIA BREAST CANCER AJCC V8 ANATOMIC STAGE IIA BREAST CANCER AJCC V8 ANATOMIC STAGE IIB BREAST CANCER AJCC V8 ANATOMIC STAGE IIB BREAST CANCER AJCC V8 ANATOMIC STAGE III BREAST CANCER AJCC V8 ANATOMIC STAGE III BREAST CANCER AJCC V8 ANATOMIC STAGE IIIA BREAST CANCER AJCC V8 ANATOMIC STAGE IIIA BREAST CANCER AJCC V8 ANATOMIC STAGE IIIB BREAST CANCER AJCC V8 ANATOMIC STAGE IIIC BREAST CANCER AJCC V8 PROGNOSTIC STAGE I BREAST CANCER AJCC V8 PROGNOSTIC STAGE I BREAST CANCER AJCC V8 PROGNOSTIC STAGE IA BREAST CANCER AJCC V8 PROGNOSTIC STAGE IA BREAST CANCER AJCC V8 PROGNOSTIC STAGE IB BREAST CANCER AJCC V8 PROGNOSTIC STAGE IB BREAST CANCER AJCC V8 PROGNOSTIC STAGE II BREAST CANCER AJCC V8 PROGNOSTIC STAGE II BREAST CANCER AJCC V8 PROGNOSTIC STAGE IIA BREAST CANCER AJCC V8 PROGNOSTIC STAGE IIA BREAST CANCER AJCC V8 PROGNOSTIC STAGE IIB BREAST CANCER AJCC V8 PROGNOSTIC STAGE IIB BREAST CANCER AJCC V8 PROGNOSTIC STAGE III BREAST CANCER AJCC V8 PROGNOSTIC STAGE III BREAST CANCER AJCC V8 PROGNOSTIC STAGE IIIA BREAST CANCER AJCC V8 PROGNOSTIC STAGE IIIA BREAST CANCER AJCC V8 PROGNOSTIC STAGE IIIB BREAST CANCER AJCC V8 PROGNOSTIC STAGE IIIB BREAST CANCER AJCC V8 PROGNOSTIC STAGE IIIC BREAST CANCER AJCC V8 REFRACTORY BREAST CARCINOMA TRIPLE-NEGATIVE BREAST CARCINOMA